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Lower risk Medical device recall · FDA · Published May 13, 2025

Philips Evolution Upgrade 3.0T MRI May Cause Image Alignment Errors

Philips recalls Evolution Upgrade 3.0T MRI systems with model numbers 782117 and 782143 due to potential alignment errors in cross reference line functionality when using MobiView app.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1794-2025Medical devicePhilips ›
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Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
✎ GovInfoNow plain-language explainer

Philips is recalling certain Evolution Upgrade 3.0T MRI systems that may cause image alignment errors when used with the MobiView application. This could lead to inaccurate medical imaging results if the cross reference line functionality is misaligned. Read more at govinfonow.com/recall/52277-philips-evolution-upgrade-3-0t-mri-may-cause-image-alignment.

Source Summary by GovInfoNow · govinfonow.com/recall/52277-philips-evolution-upgrade-3-0t-mri-may-cause-image-alignment · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1794-2025

Cite this page

“Philips Evolution Upgrade 3.0T MRI May Cause Image Alignment Errors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52277-philips-evolution-upgrade-3-0t-mri-may-cause-image-alignment. Based on FDA recall #Z-1794-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1794-2025%22&limit=1).

Philips North America Llc recalled Evolution Upgrade 3.0T imaging systems due to potential alignment errors in the MobiView application, the FDA said on May 13, 2025.

How to tell if you have it

  • Brand: Philips
  • Product Name: Evolution Upgrade 3.0T
  • Model Numbers: (1) 782117, (2) 782143
  • UDI-DI: (1) 00884838099739, (2) 00884838108660
  • Serial Numbers: (1) 42023, 42024, 42078, 42375, 42402, 42408, 71348, 85675, 85687, 85694, 85705, (2) 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85684, 85688, 85690, 85695, 85697, 85699, 85708

The hazard

The recall addresses potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Context

GovInfoNow's records show Philips North America Llc has 129 other recalls on record since 2017-07-12. Other recent recalls of similar products include Philips Evolution Upgrade 1.5T MRI Systems May Have Stiffness Errors in MRE Reports (2025-12-03), Philips Evolution Upgrade 3.0T MR Systems Recall: Stiffness Errors in MRE Reports (2025-12-03), and Philips Ingenia 3.0T CX MRI Systems Recall: Stiffness Errors in MRE Images (2025-12-03).

How to tell if you have this one

Check for model numbers 782117 or 782143 on the device. The product was sold with specific serial numbers listed in the recall notice.

  • Brand
    Philips
  • Category
    Medical device
FDA recall event · 18 products

All 18 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
    Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
Recall numberProduct, codes & lotsQuantity
Z-1788-2025Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146; Model Numbers: (1) 781260, (2) 782112, (3) 782146; UDI-DI: (1) 00884838095076,(2) 00884838098886, (3) 00884838108691; Serial Numbers: (1) 10044, 10151, 10164, 10170, 11000, 11001, 11062, 11076, 12009, 18038, 18663, 18872, 18938, 20115, 20164, 20413, 21011, 21019, 21062, 21133, 21249, 21278, 21477, 21577, 21583, 21591, 21880, 21888, 22157, 22248, 32049, 32094, 32099, 32113, 32142, 32184, 32217, 32245, 32286, 32322, 32334, 32636, 32845, 39024, 5479, 5490, 8057, 8263, 8305, 8330, 8365, 8378, 8392, 8456, 8561, 8639, 8736, 8752, 8808, 8819, 8942, (2) 10479, 12002, 13024, 18651, 21205, 21685, 22267, 30031, 39106, (3) 13013, 20414, 21202, 21990, 22251, 32116, 32407, 32683, 33611, 39040;80 units (1 US, 79 OUS)
Z-1789-2025Product Name: SmartPath to dStream for 3.0T; Model Number: 782145; Model Number: 782145; UDI-DI: 00884838095083; Serial Numbers: 17377, 17385, 34114, 34208, 38118, 38170, 38294, 38313, 38336, 73002, 73004, 74004;12 units (OUS only)
Z-1790-2025Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;; Model Numbers: (1) 781270, (2) 782113; UDI-DI: (1) 00884838095083, (2) 00884838098909; Serial Numbers: (1) 17283, 17299, 17321, 17356, 17357, 17369, 17378, 17398, 17416, 17425, 17473, 17490, 17499, 17550, 17564, 17565, 17569, 17589, 17590, 17594, 23026, 24012, 24023, 24066, 24075, 24087, 24090, 24110, 34107, 34152, 35043, 35047, 35056, 38004, 38023, 38084, 38089, 38113, 38120, 38199, 38202, 38300, 38366, (2) 17252, 17258, 17346, 24039, 24077, 24146, 34131, 34212, 35071, 38197, 38234, 38291;55 units (2 US, 53 OUS)
Z-1791-2025Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;; Model Numbers: (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42072, 42194, 42306, 71019, 71025, 71050, 85661, 85676, (2) 42062, 42105, 42323, 42346, 42441, 71278, 71504, 71508;16 units (All OUS)
Z-1792-2025Product Name: Upgrade to MR 7700; Model Number: 782130;; Model Number: 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42066, 42151, 42211, 42248, 42376, 45001, 45007, 45236, 71613, 71907, 85643, 85644;13 units (7 US, 6 OUS)
Z-1793-2025Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;; Model Numbers: (1) 782116, (2) 782148; UDI-DI: (1) 00884838099722, (2) 00884838108714; Serial Numbers: (1) 41042, 41047, 41080, 41139, 41229, 41287, 41295, 41327, 41367, 41424, 41432, 41433, 41457, 41568, 70068, 70284, 70630, 70696, 70995, 70996, 81021, (2) 41011, 41031, 41244, 41284, 41334, 41427, 41464, 41488, 41523, 41534, 41547, 70067, 70289, 70452, 70454, 70473, 70590, 70622, 70644, 70652, 70742, 70769, 70803, 70829, 70966, 70980, 84102, 84109, 84368, 84630, 84825;52 units (3 US, 49 OUS)
Z-1794-2025Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;; Model Numbers: (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42023, 42024, 42078, 42375, 42402, 42408, 71348, 85675, 85687, 85694, 85705, (2) 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85684, 85688, 85690, 85695, 85697, 85699, 85708;28 units (5 US, 23 OUS)
Z-1795-2025Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61003, 61005, 61007, 61014, 61022, 61023, 61024, 61029, 61031, 61033, 61036, 61045, 61051, 61052, 61053, 61054, 61055, 61057, 61059, 61062, 61063, 61076, 61088, 61093, 61097, 61101, 61112, 61124, (2) 70009, 70042, 70051, 70056, 70059, 70075, 70095, 70104, 70203, 70223, 70249, 70257, 70262, 70300, 70311, 70346, 70376, 70381, 70383, 70427, 70432, 70439, 70440, 70453, 70460, 70461, 70472, 70483, 70588, 70596, 70598, 70619, 70645, 70646, 70647, 70650, 70658, 70659, 70661, 70672, 70684, 70699, 70702, 70708, 70712, 70724, 70736, 70741, 70751, 70798, 70800, 70820, 70825, 70826, 70836, 70846, 70862, 70863, 70880, 70886, 70889, 70896, 70897, 70902, 70920, 70922, 70953, 70961, 70970, 70975, 70977, 70979, 70983, 70988, 70989, 84027, 84031, 84034, 84042, 84043, 84076, 84079, 84080, 84084, 84085, 84093, 84118, 84130, 84136, 84141, 84157, 84170, 84172, 84173, 84185, 84186, 84191, 84193, 84202, 84203, 84205, 84210, 84212, 84226, 84233, 84253, 84266, 84267, 84270, 84276, 84281, 84295, 84332, 84333, 84335, 84343, 84359, 84360, 84376, 84379, 84388, 84394, 84416, 84419, 84429, 84431, 84448, 84462, 84484, 84485, 84487, 84507, 84509, 84528, 84539, 84545, 84549, 84550, 84555, 84560, 84568, 84596, 84628, 84634, 84635, 84641, 84654, 84694, 84708, 84713, 84721, 84722, 84725, 84741, 84745, 84750, 84768, 84788, 84803, 84828, 84838, 84839, 84840, 84850, 84853, 84858, 84867, 84869, 84880, 84892, 84893, 84904, 84918, 84939, 84954, 84956, 84973, 84978, 87026, 87040, 87068, 87076, 87121, 87196, 87245, 87255, 87259, (3) 41000, 41003, 41021, 41029, 41033, 41034, 41055, 41061, 41071, 41088, 41109, 41123, 41131, 41174, 41182, 41215, 41216, 41249, 41251, 41254, 41255, 41259, 41262, 41311, 41312, 41336, 41349, 41356, 41358, 41363, 41370, 41384, 41387, 41388, 41389, 41400, 41402, 41412, 41422, 41499, 41500, 41515, 41538, 41548, (4) 87655, (5) 61383, 61384, 61412, (6) 45601;264 units (46 US, 218 OUS)
Z-1796-2025Product Name: Ingenia 1.5T S; Model Number: 781347;; Model Number: 781347; UDI-DI: 00884838068421; Serial Numbers: 81042, 81072;2 units (US Only)
Z-1797-2025Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;; Model Numbers: (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 71029, 71031, 71038, 71185, 71193, 71319, 71322, 71336, 71355, 71532, 71556, 71739, 71796, 85006, 85066, 85154, 85191, 85201, 71001, 71002, 71006, 71008, 71026, 71051, 71061, 71072, 71088, 71095, 71101, 71154, 71163, 71164, 71184, 71214, 71231, 71269, 71288, 71309, 71311, 71313, 71335, 71341, 71344, 71347, 71366, 71374, 71384, 71385, 71412, 71413, 71420, 71427, 71438, 71441, 71442, 71445, 71446, 71448, 71450, 71453, 71459, 71462, 71463, 71475, 71484, 71486, 71489, 71493, 71521, 71558, 71562, 71564, 71565, 71574, 71589, 71590, 71597, 71604, 71611, 71615, 71616, 71619, 71620, 71639, 71641, 71647, 71673, 71684, 71686, 71704, 71715, 71723, 71725, 71733, 71737, 71749, 71756, 71759, 71773, 71780, 71806, 71813, 71816, 71831, 71841, 71849, 71850, 71862, 71882, 71885, 71889, 71921, 71923, 71925, 71954, 71979, 71986, 71992, 71993, 71994, 85015, 85038, 85045, 85068, 85076, 85078, 85085, 85087, 85091, 85125, 85126, 85148, 85150, 85180, 85183, 85216, 85276, 85319, 85377, 85391, (2) 42033, 42036, 42098, 42196, 42238, 42247, 42293, 42342, 42352, 42389, 42416, 42002, 42010, 42011, 42012, 42014, 42015, 42037, 42048, 42132, 42153, 42164, 42219, 42220, 42224, 42230, 42250, 42252, 42265, 42292, 42303, 42305, 42319, 42321, 42330, 42332, 42399, 42409, 42412, 42419, 42425, (3) 85652, 85653, 85654, 85679, 85683, 85701, 85714, 85601, 85604, 85606, 85686, 85723;193 units (36 US, 157 OUS)
Z-1798-2025Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;; Model Numbers: (1) 781359, (2) 782108, (3) 782139; UDI-DI: (1) 00884838090057, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 48001, 48005, 48009, 48011, 48014, 48016, 48023, 48033, 48034, 48043, 48045, 48047, 48122, 48154, 48160, 48167, 48173, 48178, 48179, 48180, 48242, 48275, 48285, (2) 48501, 48503, 48507, 48524, 48530, 48537, 48548, 48549, 48557, 48564, 48566, 48568, 48569, 48571, 48576, 48577, 48580, 48582, 48588, 48589, 48591, 48595, 48607, 48608, 48612, 48614, 48620, 48628, 48638, 48641, 48666, 48667, 48668, 48669, 48671, 48672, 48673, 48686, 48688, 48692, 48694, 48695, 48696, 48697, 48698, 48718, 48721, 48726, 48749, 48778, 48818, 48819, 48831, 48847, 48854, 48878, 48888, 48895, 48907, (3) 29000, 29003, 29005, 29006, 29008, 29009, 29010, 29011, 29012, 29013, 29014, 29015, 29016, 29017, 29018, 29019, 29020, 29021, 29022, 29023, 29025, 29026, 29027, 29029, 29030, 29031, 29032, 29033, 29034, 29035, 29038, 29039, 29040, 29042, 29043, 29045, 29046, 29047, 29048, 29049, 29050, 29052, 29053, 29054, 29055, 29057, 29058, 29060, 29062, 29063, 29064, 29065, 29066, 29067, 29068, 29069, 29070, 29071, 29076, 29078, 29079, 29081, 29083, 29084, 29085, 29088, 29089, 29091, 29093, 29105;152 units (25 US, 127 OUS)
Z-1799-2025Product Name: Ingenia 1.5T CX; Model Number: 781262;; Model Number: 781262; UDI-DI: 00884838068445; Serial Numbers: 77059, 77120, 77158, 77161, 77178, 77182, 77191, 77193, 77203;9 units (OUS Only)
Z-1800-2025Product Name: Ingenia 3.0T CX; Model Number: 781271;; Model Number: 781271; UDI-DI: 00884838068452; Serial Numbers: 78012, 78016, 78017, 78018, 78025, 78028, 78033, 78035, 78039, 78042, 78045, 78050, 78053, 78060, 78062, 78082, 78095, 78100, 78112, 78122, 78123, 78133, 78147, 78148, 78155, 78175, 78197, 78199, 78201, 78202, 78217, 78229, 78239, 78259, 78260, 78286, 78287;37 units (OUS Only)
Z-1801-2025Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;; Model Numbers: (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622; Serial Numbers: (1) 47002, 47004, 47011, 47012, 47018, 47019, 47020, 47028, 47029, 47037, 47049, 47052, 47057, 47099, 47173, 47184, 47187, 47189, 47200, 47203, 47204, 47206, 47211, 47215, 47222, 47230, 47231, 47242, 47245, 47252, 47258, 47260, 47268, 47270, 47274, 47281, 47283, 47286, 47290, 47294, 47297, 47301, 47304, 47309, 47312, 47313, 47314, 47328, 47342, 47347, 47351, (2) 47503, 47505, 47507, 47508, 47514, 47519, 47520, 47522, 47530, 47535, 47536, 47539, 47543, 47558, 47560, 47561, 47562, 47563, 47567, 47568, 47572, 47580, 47595, 47596, 47598, 47599, 47608, 47610, 47614, 47615, 47622, 47623, 47634, 47642, 47646, 47649, 47651, 47653, 47654, 47657, 47661, 47662, 47663, 47668, 47669, 47671, 47678, 47681, 47682, 47685, 47687, 47689, 47692, 47694, 47697, 47698, 47702, 47706, 47708, 47709, 47710, 47717, 47718, 47721, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47748, 47751, 47760, 47761, 47762, 47767, 47771, 47778, 47779, 47780, 47781, 47782, 47783, 47789, 47796, 47797, 47800, 47801, 47808, 47809, 47812, 47815, 47816, 47817, 47818, 47820, 47822, 47826, 47834, 47839, 47843, 47844, 47849, 47851, 47862, 47863, 47866, 47876, 47882, 47885, 47886, 47887, 47891, 47928, (3) 49000, 49001, 49002, 49003, 49004, 49008, 49009, 49010, 49013, 49014, 49015, 49017, 49019, 49020, 49021, 49025, 49026, 49027, 49029, 49031, 49033, 49034, 49036, 49043, 49044, 49045, 49047, 49048, 49049, 49052, 49053, 49054, 49056, 49057, 49058, 49060, 49062, 49063, 49064, 49066, 49067, 49068, 49069, 49070, 49071, 49072, 49073, 49075, 49076, 49077, 49078, 49079, 49080, 49081, 49086, 49087, 49088, 49089, 49090, 49091, 49092, 49093, 49094, 49095, 49096, 49097, 49098, 49099, 49100, 49101, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49111, 49113, 49114, 49115, 49116, 49117, 49118, 49119, 49121, 49124, 49128, 49129, 49130, 49131, 49134, 49136, 49140, 49144, 49145, 49146, 49147, 49148, 49152, 49153, 49154, 49155, 49156, 49157, 49158, 49160, 49161, 49162, 49163, 49164, 49165, 49166, 49168, 49171, 49172, 49178, 49179, 49180, 49181, 49182, 49183, 49186, 49197, 49203, 49205, 49212, 49217, 49226, 49227, 49231;300 units (81 US, 219 OUS)
Z-1802-2025Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;; Model Numbers: (1) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615; Serial Numbers: (1) 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, (2) 46203, 46206, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46237, 46241, 46242, 46243, 46245, 46258, 46268, 46269, 46270, 46286, 46292, 46326, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64045;65 units (6 US, 59 OUS)
Z-1803-2025Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;; Model Numbers: (1) 781358, (2) 782107, (3) 782136; UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838108608; Serial Numbers: (1) 45010, 45023, 45028, 45029, 45032, 45033, 45034, 45037, 45040, 45041, 45043, 45045, 45046, 45048, 45049, 45053, 45066, 45070, 45072, 45076, 45087, 45090, 45091, 45092, 45093, 45102, 45105, 45108, 45115, 45116, 45119, 45127, 45136, 45138, 45140, 45144, 45147, 45154, 45156, 45157, 45162, 45168, 45181, 45184, 45189, 45191, 45194, 45205, 45222, 45227, 45231, 45243, 45244, 45245, 45246, 45250, 45252, 45263, 45272, 45277, 45278, 45289, 45290, 45296, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45362, 45374, 45379, 45414, (2) 45503, 45508, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45543, 45545, 45547, 45551, 45559, 45560, 45561, 45568, 45573, 45574, 45578, 45580, 45589, 45594, 62011, 62023, 62024, 62026, 62030, 62031, 62033, 62035, 62038, 62040, 62041, 62047, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62065, 62070, 62071, 62073, 62080, 62081, 62082, 62083, 62088, 62092, 62134, 62136, 62137, 62152, 62153, 62159, 62178, 62181, 62182, 62191, 62197, 62198, 62199, 62212, (3) 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28517, 28518, 28520, 28521, 28523, 28524, 28525, 28526, 28527, 28528, 28529, 28531, 28532, 28533, 28535, 28536, 28537, 28538, 28539, 28540, 28542, 28543, 28545, 28546, 28547, 28548, 28550, 28552, 28554, 28555, 28559, 28560, 28561, 28563, 28564, 28565, 28566, 28568, 28569, 28572, 28575, 28581;198 units (25 US, 173 OUS)
Z-1804-2025Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;; Model Numbers: (1) 782110, (2) 782152; UDI-DI: (1) 00884838099364, (2) 00884838112841; Serial Numbers: (1) 63007, 63011, 63022, 63043, 63047, 63050, 63051, 63060, 63074, 63078, 63079, 63082, 63085, 63090, 63095, 63097, 63100, 63116, 63121, 63132, 63136, 63137, 63142, 63143, 63144, 63146, 63150, 63156, 63160, 63162, 63166, 63190, 63202, 63210, 63222, 63226, 63228, 63235, 63238, 63239, 63244, 63247, 63258, 63262, 63263, 63264, 63265, 63266, 63267, 63268, 63269, 63270, 63272, 63274, 63275, 63276, 63281, 63282, 63283, 63284, 63285, 63286, 63287, 63288, 63289, 63290, 63292, 63300, 63303, 63304, 63305, 63306, 63307, 63337, 63352, 63356, 63361, 63363, 63366, 63367, 63370, 63372, 63394, 63456, 63596, 63599, (2) 69000, 69003, 69004, 69005, 69006, 69007, 69008, 69010, 69011, 69012, 69014, 69015, 69016, 69017, 69019, 69020, 69021, 69022, 69023, 69024, 69026, 69027, 69029, 69031, 69032, 69034, 69036, 69037, 69041, 69043, 69044, 69045, 69046, 69048, 69051, 69052, 69053, 69055, 69056, 69058, 69060, 69061, 69063, 69064, 69065, 69066, 69067, 69068, 69069, 69070, 69071, 69072, 69073, 69075, 69076, 69077, 69078, 69080, 69081, 69082, 69085, 69086, 69087, 69089, 69092, 69093, 69094, 69095, 69096, 69097, 69098, 69100, 69102, 69103, 69106, 69107, 69110, 69111, 69112, 69115, 69116, 69121, 69122, 69123, 69124, 69126, 69127, 69130, 69131, 69133, 69136, 69137, 69141, 69147, 69150, 69161, 69170, 69171, 69172, 69176;186 units (2 US, 184 OUS)
Z-1805-2025Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;; Model Numbers: (1) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000, 65001, 65002, 65003, 65004, 65005, 65007, 65008, 65009, 65011, 65012, 65013, 65014, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65037, 65038, 65039, 65040, 65041, 65042, 65050, 65051, 65056, 65057, 65059, 65060, 65061, 65063, 65064, 65065, 65066, (2) 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68011, 68012, 68013, 68014, 68015, 68016, 68017, 68018, 68020, 68023, 68024, 68025, 68028, 68029, 68030, 68031, 68034, 68037;72 units (6 US, 66 OUS)
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Identify the model number on your device to see if it is 782117 or 782143.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 15 days after the firm started it.

1. Firm started the recall: May 13, 202512. FDA classified it Class II: May 16, 202523. Published in FDA’s Enforcement Report: May 28, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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-1794-2025 (May 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1794-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA