Lower risk Medical device recall · FDA · Published June 10, 2025
SEDECAL MobileDiagnost wDR 2.2 Mobile X-ray System: Not Water-Resistant
SEDECAL recalls MobileDiagnost wDR 2.2 mobile X-ray systems (model REF 9890-010-89522) due to not being water-resistant. Users must clean strictly per manual to avoid damage.
Lower-risk recall
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Contact the company
Recalling firmSEDECAL SAPelaya, 9 Pol., Pol. Ind. Rio De Janeiro · Algete, Spain
What happened, in plain English
SEDECAL is recalling its MobileDiagnost wDR 2.2 mobile X-ray systems (model REF 9890-010-89522) because they are not water-resistant. Improper cleaning could cause damage to the equipment. Read more at govinfonow.com/recall/52084-sedecal-mobilediagnost-wdr-2-2-mobile-x-ray-system-not.
Source Summary by GovInfoNow · govinfonow.com/recall/52084-sedecal-mobilediagnost-wdr-2-2-mobile-x-ray-system-not · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0243-2026
Cite this page
“SEDECAL MobileDiagnost wDR 2.2 Mobile X-ray System: Not Water-Resistant.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52084-sedecal-mobilediagnost-wdr-2-2-mobile-x-ray-system-not. Based on FDA recall #Z-0243-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0243-2026%22&limit=1).
Why it’s dangerous
The equipment is not designed to be water-resistant, so improper cleaning could cause damage. Sedecal's email reminds users to follow cleaning instructions in the manual to avoid issues.
Who’s affected
Users of the MobileDiagnost wDR 2.2 mobile X-ray systems with model number REF 9890-010-89522 are affected. Healthcare facilities using this equipment are most at risk.
How to tell if you have this one
Check for the model number REF 9890-010-89522 on the MobileDiagnost wDR 2.2 mobile X-ray system. The recall includes specific serial numbers listed in the record.
- Brand
SEDECAL- Category
Medical device
All 46 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US: CA, IL, and NJ
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0242-2026 | Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30); UDI/DI 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846. | 56 units |
| Z-0243-2026 | MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system; UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15100127, 15100131, 15100135, 15100138, 15100144, 15100133, 14100034, SN14000127, 15100191, 66690596, 66936848, 15100274, 15100280, 15100276, SN16100008, 16100011, 67905914, 16100037, 16100038, 68025890, 68052381, 68054442, 68199970, 68233849, 68268597, 12000085, 68530038, 16200084, 16200028, 16200029, 16200049, 16200050, 16200051, 69022933, 16200064, 16200099, 70240554, 70378102, 70544668, 70545417, 70705340, 71001729, 72299716, 72555189, 21410094, 21410261, 21410347, 21410348, 22410146, 97579477, 97808946, 22410333, 17200007, 17200002, SN16200130, 16200129, 70929667, 16200137, 16200136, SN17200073, SN17200056, SN17200131, SN17200140, SN17200162, SN17200161, SN17200174, SN17200173, SN17200175, SN17200168, SN17200167, 16200049, SN17200217, 17200167, 17200168, SN18200010, SN18200011, SN18200049, SN18200088, SN18200112, SN18200133, SN18200124, 74854394, 75716470, SN18200176, SN18200186, SN18200209, SN18200341, 18200206, 18200205, SN19300073, SN19300085, SN19300098, 16, SN19300035, SN19300088, SN19300091, SN19300099, SN19300109, 23410012, SN21410184, SN19410126, 27, SN19410129, 23410046, 19410044, 19410046, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410320, 21410329, 21410330, 21410331, 21410332, 21410333, 21410334, 21410339, 21410340, 21410341, 21410342, 21410345, 21410349, 21410351, 21410360, 21410361, 21410362, 21410363, 21410365, 21410366, 21410367, 21410368, 21410369, 21410378, 21410379, 21410383, 21410384, 21410394, 21410402, 21410409, 21410410, 21410413, 21410414, 21410436, 22410002, 22410003, 22410021, 22410022, 22410023, 22410032, 22410033, 22410034, 22410035, 22410036, 22410050, 22410093, 22410121, 22410122, 22410132, 22410133, 22410142, 22410143, 22410145, 22410152, 22410153, 22410154, 22410155, 22410158, 22410159, 22410160, 22410161, 22410163, 22410164, 22410165, 22410189, 22410194, 22410195, 22410196, 22410197, 22410198, 22410199, 22410200, 22410201, 22410202, 22410203, 22410204, 22410218, 22410219, 22410226, 22410229, 22410236, 22410237, 22410238, 22410239, 22410245, 22410246, 22410247, 22410248, 22410251, 22410253, 22410315, 22410317, 22410318, 22410319, 22410320, 22410321, 22410322, 22410328, 22410331, 22410332, 23410008, 23410009, 23410010, 23410027, 23410040, 23410043, 23410044, 23410045, 23410047, 23410071, 23410072, 23410073, 23410078, 23410079, 23410080, 23410081, 23410086, 23410087, 23410088, 23410089, 23410090, 23410091, 23410092, 23410099, 23410102, 23410108, 23410120, 23410121, 23410122, 23410124, 23410125, 23410128, 23410133, 23410134, 23410135, 23410138, 23410139, 23410152, 23410164, 23410167, 23410171, 23410172, 23410174, 23410175, 23410176, 23410177, 23410193, 23410247, 23410257, 23410269, 23410270, 24410107, 24410146, 24410148, 24410149, 24410151, 24410168, 214410346, 214411180, 214411229, 23410118, SN0410157, SN1410049, SN19410034, SN19410035, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, 20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410103, SN21410104, SN21410105, 21410117, SN21410118, SN21410119, SN21410130, SN21410131, 21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, 21410213, 21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, SNZY204110015, 485059/SN11000013, 485060/SN11000015, 485062/SN11000009, 485061/SN11000012, 488170/SN11000010, 488169/SN11000011, 489089/SN11000016, 489694/SN11000035, 489696/SN11000037, 489616/SN11000033, 490027/SN11000034, 489695/SN11000036, 489088/SN11000040, 490221/SN11000039, 492411/SN11000014, 492417/SN11000048, 493565/SN11000048, 493566/SN11000047, 494456/SN11000055, 494941/SN11000052, 494464/SN11000065, 488171/SN11000068, 494864/SN11000060, 494865/SN11000056, 494866/SN11000062, 494867/SN11000051, 495286/SN11000061, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494064/SN11000074, 494065/SN11000075, 494063/SN11000073, 496446/SN11000082, 496448/SN11000057, 497570/SN11000066, 496387/SN12000003, 497715/SN11000080, 495938/SN12000007, 12000008, 493364/SN12000022, 493462/SN12000023, 500740/SN12000028, 501028/SN12000026, 500739/SN12000027, 502424/SN12000034, 503141/SN12000038, 503142/SN12000037, 503143/SN12000036, 503144/SN12000039, 503380/SN12000044, 502721/SN12000047, 505077/SN12000048, 500466/SN12000045, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 496401/SN12000059, 500467/SN12000060, 500468/SN12000058, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 509633/SN12000069, 509640/SN12000071, 510607/SN12000072, 512879/SN12000076, 512160/SN12000077, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 512892/SN12000082, 508699/SN12000088, 514103/SN12000092, 514104/SN12000091, 514461/SN12000090, 514462/SN12000089, 513477/SN12000080, 513478/SN12000081, 516891/SN12000110, 516896/SN12000111, 509062/SN12000107, 497572/SN12000112, 508783/SN12000108, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 519762/SN13000018, 520251/SN13000016, 519506/SN13000011, 520253/SN13000017, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520416/SN13000031, 520252/SN13000027, 520421/SN13000032, 520422/SN13000028, 520417/SN13000033, 520418/SN13000030, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000060, 13000054, 13000056, 13000058, 13000057, 13000055, SN13000074, 13000075, 13000070, 13000071, SN13000073, SN13000069, SN13000072, 13000077, 13000078, SN13000084, SN13000083, SN13000091, 13000090, SN13000104, SN13000107, SN13000106, SN13000102, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000142, 13000141, 13000140, 13000139, 13000143, 13000144, SN13000147, SN13000154, SN13000153, 13000158, SN13000157, SN13000160, SN13000164, 13000177, 13000163, SN13000176, 13000165, SN13000174, SN13000180, SN13000183, SN13000185, SN13000182, 14000010, 13000199, 13000196, SN13000206, 13000203, 13000205, 13000204, 14000004, 14000005, 13000202, 14000006, 14000024, 14000022, 14000028, 14000032, 14000031, 14000029, 14000033, 14000034, 14000037, 14000038, 14000046, 14000048, 14000050, SN14000061, 14000069, 14000075, 14000072, 14000077, 14000080, 14000079, 14000081, 14000078, 14000084, 14000082, 14000086, 14000087, 14000088, 14000089, 14000043, SN14000098, SN14000099, SN14000100, 14000103, 14000106, 14000085, 14000112, 14000120, 14000121, 14000122, 14000124, 14000127, 14000092, SN14100071, SN14100072, SN14100073, SN14000130, SN14100074, SN14100075, SN14100047, 14100053, SN14100046, 14100044, 14100045, SN14100055, 14100054, 14000134, 14100087, 14100086, 14100088, 14100085, 14000135, 14100090, 14100097, 14100094, 14100095, 14100101, 14100109, 14100111, 14000138, 14000139, 14100117, 14100126, 14100128, 14100127, SN15100009, SN15100011, SN15100016, SN15100018, SN15100020, SN15000002, 15100023, 15100019, 15100034, 15100048, 15100047, 15100036, 15100035, 15100050, 15100028, 15100071, 15100039, 15100084, 15100085, 15100089, 15100088, 15100094, 15100091, 15100092, 15100087, 15100093, 15100098, 15100097, 15100099, 15100103, 15100101, 15100122, 15100121, 15100120, 15100119, 15100118, 15100128, 15100129, 15100117, 15100123, 15100130, 15100132, 15100139, 15100140, 15100137, 15100134, 15100136, SN15100150, SN15100148, SN15100149, SN15100153, SN15100030, SN15100151, SN15100158, SN15100155, SN15100157, 15100166, 15100162, 15100165, 15100169, 15100172, 15100171, 15100173, 15100178, 15100170, 15100161, 15100168, SN15100179, SN15100181, SN14000126, 15100195, 15100196, 15100211, 15100214, 15100219, 15100222, 15100223, 15100227, 15100228, 15100229, 15100230, 15100233, 15100238, 15100253, 15100249, SN15100255, SN15100260, 15100266, 15100268, 15100270, 15100271, 15100273, 15100275, 15100277, 16100005, 16100007, SN16100012, 16100028, 16100029, 16100033, 16100034, 16100041, 16100042, 16100045, 16100047, 16100049, 16100061, 16100062, 16100065, 16200010, 16200030, 16200033, 16200027, 16200034, 16200036, 16200045, 16200046, 16200052, 16200058, 16200059, 16200057, 16200043, 16200062, 16200063, 16200065, 16200069, 16200076, SN16200077, 16200078, 16200074, 16200075, 16200089, 16200085, 16200086, 16200087, 16200101, 16200102, 16200103, 16200107, 16200108, 16200135, 16200127, SN16200126, 16200138, 16200139, 16200140, 16200157, 16200152, 16200159, 17200003, 17200004, 17200005, 17200006, 17200011, 17200014, 17200019, 17200020, 17200024, 17200025, 17200027, 17200026, 17200033, 17200030, 17200032, 17200038, 17200043, 17200037, SN17200049, 17200058, 71573917, 17200060, 17200061, SN17200055, 17200059, SN17200066, SN17200067, SN17200072, SN17200083, SN17200082, SN17200084, SN17200087, 17200086, SN17200089, SN17200088, SN17200096, SN17200097, SN17200100, SN17200101, SN17200102, SN17200098, SN17200099, SN17200091, SN17200106, SN17200112, SN17200113, 17200114, SN17200115, SN17200121, SN17200123, SN17200126, SN17200125, SN17200130, SN17200129, SN17200128, SN17200127, SN17200134, SN17200135, SN17200138, SN17200137, SN17200139, SN17200136, SN17200152, SN17200160, SN17200159, SN17200158, SN17200177, SN17200176, SN17200172, SN17200171, SN17200157, SN17200166, 17200165, SN17200164, SN17200163, SN17200181, SN17200189, SN17200187, SN17200192, SN17200191, SN17200188, SN17200182, SN17200204, SN17200205, SN17200207, SN17200202, SN17200201, SN17200196, SN17200195, SN17200219, SN17200194, SN17200197, SN17200220, SN17200200, SN17200224, SN17200198, SN17200237, SN17200236, 17200235, SN17200239, SN18200009, SN18200008, SN18200007, 18200042, SN18200040, SN18200041, 8200039, SN18200013, SN18200036, 18200044, 18200031, 18200047, 18200033, SN18200037, 18200045, 18200046, 18200038, 18200048, SN18200034, SN18200012, SN18200043, SN18200058, SN18200059, SN18200032, SN18200061, SN18200057, 18200056, SN18200068, SN18200071, SN18200081, SN18200082, SN18200084, SN18200086, SN18200085, SN18200072, SN18200116, SN18200117, SN18200035, SN18200067, SN18200096, SN18200110, SN18000087, SN18200127, SN18200070, SN18200139, SN18200138, SN18200095, SN18200109, SN18200123, SN18200137, SN18200140, SN18200141, SN18200159, SN18200154, SN18200160, 18200171, SN18200169, SN18200161, SN18200167, SN18200166, SN18200165, SN18200173, SN18200175, SN18200174, SN18200183, SN18200185, SN18200187, SN18200208, SN18200203, SN18200205, SN18200206, SN18200189, SN18200194, SN18200211, SN18200215, SN18200200, SN18200216, SN18200217, SN18200218, SN18200219, SN18200222, SN18200231, SN18200244, SN18200210, SN18200232, SN18200233, SN18200234, SN18200254, SN18200256, SN18200257, SN18200261, SN18200259, SN18200258, SN18200271, SN18200260, SN18200288, SN18200292, SN18200310, SN18200315, SN18200314, SN18200245, SN18200332, SN18200334, SN18200236, SN18200237, SN18200335, SN18200337, SN18200344, SN18200343, SN19300001, SN19300002, SN19300030, SN19300007, SN19300023, SN19300026, SN19300032, SN19300033, SN19300040, SN19300043, SN19300028, SN19300024, SN19300063, SN19300044, SN19300066, SN19300067, SN19300016, SN19300070, SN19300076, SN19300075, SN19300074, SN19300072, SN19300005, SN19300077, 24410156, 24410155, 24410154, 24410153, 24410152, 24410150, 24410147, 24410145, 24410144, 24410143, 24410142, 24410141, 25410027, 25410026, 25410024, 25410023, 25410022, 25410021, 25410018, 25410017, 25410016, 25410015, 25410014, 25410013, 25410012, 25410011, 25410010, 25410009, 25410008, 25410007, 25410005, 25410004, 25410003, 25410002, 25410001, 24410185, 24410184, 24410183, 24410181, 24410180, 24410176, 24410175, 24410174, 24410172, 24410171, 24410170, 24410162, 24410161, 24410160, 24410035, 24410028, 24410025. | 1198 units |
| Z-0244-2026 | Model Number 40KWFX, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G71453, G70953, G70930, G70537, G70757, G70797, G70275, G71257, G71983, G71975, G71467, G69702, G71440, G71329, G70244, G70955, G71462, G71320, G71451, G71466, G71335, G71446, G65260, G70951, G70814, G70931, G70942, G71991, G70261, G72080, G69697, G71978, G70938, G70247, G70250, G70947, G69706, G78917, G70943, G71343, G71345, G71346, G71258, G70527, G69551, G71442, G71977, G71987, G72083, G70242, G72111, G70256, G70806, G71339, G69547. | 55 units |
| Z-0245-2026 | Model Number 40KW-FX.899, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G72770 | 1 unit |
| Z-0246-2026 | Model Number 40KWFXPLUS, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017, G80154, G73616, G73471, G76479, G79615, G80179, G79467, G79827, G79840, G79877, G79926, G78011, G78726, G82574, G82638, G73651, G75438, G77820, G78050, G79426, G79634, G82590, G72392, G73520, G73524, G73627, G73642, G73653, G76730, G76888, G78212, G78279, G78296, G78305, G78323, G82156, G83117, G83133, G73624, G82557, G84603, G84633, G84634, G84641, G84642, G84753, G84778, G84795, G84857, G84869, G84882, G84884, G84900, G84901, G84902, G84911, G84912, G85513, G85514, G85516, G85527, G85528, G79115, G79915, G72362, G75112, G75515, G79299, G79324, G73453, G79625, G77328, G75676, G75744, G75439, G78129, G78141, G76110, G76545, G78000, G80042, G73460, G75100, G75502, G84782, G79794, G83972, G84025, G79936, G84487, G75404, G73457, G75085, G79927, G75388, G73609, G76560, G78992, G82079, G82095, G84014, G75375, G75503, G75516, G73621, G73648, G72971, G77213, G79889, G77605, G79311, G75961, G77789, G84028, G73015, G73063, G78873, G79663, G79275, G73027, G76887, G79277, G79357, G76126, G75980, G76125, G76844, G77073, G77089, G77191, G77425, G73079, G75867, G83920, G84017, G77609, G77653, G84591, G75904, G75905, G73147, G73059, G77583, G77641, G77768, G77854, G77870, G77928, G84038, G72363, G73052, G75661, G75662, G75691, G84052, G72972, G73084, G73119, G76757, G76803, G84066, G77780, G73040, G73038, G73139, G75705, G76156, G76721, G84064, G79616, G82140, G82141, G82159, G83203, G75012, G79183, G79806, G70809, G79037, G79182, G80186, G76831, G77408, G79899, G82499, G75451, G75111, G73469, G82158, G80068, G84867, G75114, G75437, G77338, G76250, G77218, G77394, G79432, G79025, G83227, G79102, G79427, G77788, G75011, G75039, G83228, G79060, G78090, G80244, G80090, G82558, G76109, G72422, G75422, G76285, G77178, G78009, G78023, G78052, G78062, G78080, G78697, G78713, G78749, G78896, G79585, G79623, G82157, G83105, G83137, G77144, G75592, G76234, G76579, G78947, G77123, G82591, G78962, G79105, G80180, G79341, G79393, G84754, G76439, G75387, G73463, G73472, G79297, G80153. | 268 units |
| Z-0247-2026 | Model Number 40KWFXPLUS.002, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G73508, G73512, G71323, G72419, G78910, G72425, G83214, G70934. | 8 units |
| Z-0248-2026 | Model Number 40KWFXPLUS.004, Mobile X-ray system; UDI/DI unknown, Serial Numbers: G84489, G84504, G84589. | 3 units |
| Z-0249-2026 | Model Number 40KWFXPLUS.005, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G82576, G82871, G72391, G74872, G75722, G76782, G75035, G75723, G78884, G70532, G73630, G82077. | 12 units |
| Z-0250-2026 | Model Number 40KWFXPLUS.889, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G77146 | 1 unit |
| Z-0251-2026 | Model Number 40KWFXPLUS-710CW, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605. | 12 units |
| Z-0252-2026 | Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G79192, G79195, G79212, G78205, G80256, G79692, G80053. | 7 units |
| Z-0253-2026 | Model Number 40KWMOBILE3.899, Mobile X-ray system; UDI/DI unknown, Serial Numbers: G64852 | 1 unit |
| Z-0254-2026 | Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system; UDI/DI 08436046001091, Serial Numbers: G23218 | 1 unit |
| Z-0255-2026 | Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system; UDI/DI unknown, Serial Numbers: G22915, G23633, G23828, G20560, G21319, G24800, G19667, G20347. | 8 units |
| Z-0256-2026 | Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system; UDI/DI 08436046001466, Serial Numbers: G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, G38069, G-40590, G41143, G62020, G69393, G38082, G41163, G60166, G26244, G40196, G60461, G33309. | 22 units |
| Z-0257-2026 | Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G-33126, G31259, G35641, G35630, G35718, G37357. | 6 units |
| Z-0258-2026 | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684. | 39 units |
| Z-0259-2026 | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G37528 | 1 unit |
| Z-0260-2026 | Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G13768, G36626, G62493, G39518, G61725, G36211, G36281, G36573, G36581, G61368, G61880, G62037, G61367, G36227. | 14 units |
| Z-0261-2026 | Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system; UDI/DI 08436046001114, Serial Numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240. | 9 units |
| Z-0262-2026 | Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system; UDI/DI 08436046001527, Serial Numbers: 151248, G23340, C05006-W, G22215, G27497/584, 7034, G25402, G25910. | 8 units |
| Z-0263-2026 | Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G32487, 31414, G35462, G32657. | 4 units |
| Z-0264-2026 | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system; UDI/DI unknown, Serial Numbers:G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570, G31077, G29426, G33144, G29416, G30160, G30685, G33723, G30165. | 27 units |
| Z-0265-2026 | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G35462, G-32753, G35480, G33111, G33721. | 5 units |
| Z-0266-2026 | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G33585 | 1 unit |
| Z-0267-2026 | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G-33103, G35422, G35504, G33127, G33646. | 5 units |
| Z-0268-2026 | Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G35524, G33711. | 2 units |
| Z-0269-2026 | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G37587. | 1 unit |
| Z-0270-2026 | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G35611, G37536, G37588, G37490. | 4 units |
| Z-0271-2026 | Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892, G62943, G41083, G41100, G36217, G36537, G60066, G61812, G61812, G63322, G40016, G41203, G41222, G60061, G60063, G60064, G36732, G36751, G41119, G62480, G60418, G61707, G65172, G39639, G41104, G36526, G36601, G37129, G37209, G41244, G62015, G40024, G62828, G60429, G61818, G61873, G60065, G61786, G37430, G36148, G39650, G64186, G65400, G64854, G62626, G62660, G62684, G62687, G62747, G62750, G62762, G62938, G63484, G62804, G64206, G64813, G64179, G62500, G62502, G62565, G62690, G62860, G62867, G62883, G62891, G62947, G36222, G60415, G60070, G37646, G61715, G39589, G37466, G38292, G38173, G38058, G38293, G60069, G62816, G63335, G36244, G36492, G37442, G38613, G40124, G40211, G38190, G40199, G62567, G39809, G38287, G37196, G41256, G61872, G62029, G64891, G62682, G62900, G61311, G37239, G38279, G37678, G38076, G61307, G39808, G40133, G62821, G64883, G60058, G60062, G61867, G37676, G40203, G37422, G62815, G36468, G37413, G40216, G41058, G41066, G63212, G41267, G40227, G60430, G63318, G63328, G63333, G41108, G41109, G61716, G60518, G60652, G61356, G60520, G60597, G39800, G39801, G60582, G39657, G62030, G65393, G65395, G39782, G39791, G61706, G61795, G62053, G62062, G62011, G64512, G64520, G65289, G60576, G60606, G60631, G61339, G39465, G61333, G61337, G38629, G62511, G41218, G60635. | 181 units |
| Z-0272-2026 | Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G62066 | 1 unit |
| Z-0273-2026 | Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G37158, G61698, G62863, G41192, G62814, G41098, G62566, G60400, G63392, G60406. | 10 units |
| Z-0274-2026 | Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G39822, G62662, G62564, G61702, G60067, G38060. | 6 units |
| Z-0275-2026 | Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G41234 | 1 unit |
| Z-0276-2026 | Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G36566 | 1 unit |
| Z-0277-2026 | Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G65281, G60407, G65682, G64582, G64789, G70752, G65384, G65418, G67250, G68470, G70521, G70524, G70913, G70914, G65166, G63507, G64205, G64842, G71447, G65175, G65382, G64793, G64798, G40226, G72434, G65554, G67230, G37280, G65174, G65558, 15033R, G64271, G64713, G64849, G65168, G71272, G71309, G65284, G72955, G65043, G70919, G72429, G72789, G70928, G72776, G72766, G63409, G63418, G64893, G66907, G65588, G65402, G73096, G73131, G71269, G71750, G71762, G71267, G71727, G71732, G71745, G71755, G71761, G66892, G65275, G70922, G73154, G64505, G65744, G73033, G73134, G64941, G63489, G65036, G64256, G72976, G73092, G73145, G64196, G64945, G72412, G73074, G65414, G71726, G71743, G64807, G66872, G67257, G40208, G64885, G38391, G39467, G39818, G65408, G70748, G37108, G6715, G67232, G71277, G71286, G64604, G37406, G40004, G63223, G63224, G63232, G61711, G71271, G71302, G72790, G64500, G65269, G65692, G65290, G65691, G66862, G65283, G64189, G70744, G64812, G70755, G65286, G65266, G72760, G66884, G64601, G71300, G67185, G63495, G64890, G72780, G64607, G63488, G63494, G71285 - NCR1161, G63501, G41245, G64797, G64819, G64855, G72803, G41213. | 142 units |
| Z-0278-2026 | Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G39544, G62558, G71736, G40116, G65568, G65570. | 6 units |
| Z-0279-2026 | Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G64274, G40012, G64597, G70742, G72764, G61804. | 6 units |
| Z-0280-2026 | Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G38652, G37633, G36042, G37641, 608A, G36681. | 6 units |
| Z-0281-2026 | RADPRO MOBILE, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G30567, G31256, G32581, G30250, G28320, G30902, G29864, G35389, G30960, G33238, G31252, G33708, G30771, G33634, 31412, 31480, G33004, G33112, G33585, G31271, G31285, G32514, G32498, G35665. | 24 units |
| Z-0282-2026 | SED URS LP, Mobile X-ray system; UDI/DI unknown, Serial Numbers: 40116 | — |
| Z-0283-2026 | SHIMADZU RF.004, Mobile X-ray system; UDI/DI unknown, Serial Numbers: 75723 | — |
| Z-0284-2026 | SM_40HF_B_D_VIR3, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452. | 17 units |
| Z-0285-2026 | SM_40HF_B_D_VIR3.004, Mobile X-ray system; UDI/DI 08436046002166, Serial Numbers: G73023, G87352, G80066. | 3 units |
| Z-0286-2026 | SM_40HF_BDC, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: 31526 | 1 unit |
| Z-0287-2026 | SM_40HF_BDC3, Mobile X-ray system; UDI/DI 08436046001510, Serial Numbers: G41213 | 1 unit |
What to do — step by step
Follow Cleaning Instructions
Clean the equipment strictly according to the manual to avoid damage.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US: CA, IL, and NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, New Jersey.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0243-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0243-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.