Lower risk Medical device recall · FDA · Published June 17, 2026
Philips Azurion X-Ray System Recall: Unauthorized Hard Drive Risk
Philips recalls Azurion 3 M12, M15, 5 M12, 5 M20, 7 B12, 7 B20, 7 M12, and 7 M20 X-ray systems with specific model numbers due to potential loss of imaging functionality from unauthorized hard drives.
Lower-risk recall
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
What happened, in plain English
Philips is recalling specific models of their Azurion X-ray systems because unauthorized hard drives could cause imaging functionality to fail. This means the system might not work properly or lose data. Affected users should check their model numbers against the list provided. Read more at govinfonow.com/recall/314343-philips-azurion-x-ray-system-recall-unauthorized-hard-drive-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/314343-philips-azurion-x-ray-system-recall-unauthorized-hard-drive-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2892-2026
Cite this page
“Philips Azurion X-Ray System Recall: Unauthorized Hard Drive Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314343-philips-azurion-x-ray-system-recall-unauthorized-hard-drive-risk. Based on FDA recall #Z-2892-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2892-2026%22&limit=1).
Why it’s dangerous
Unauthorized hard drives can cause the X-ray system to lose imaging functionality or data. This means the system might not work properly or could lose critical medical imaging information during use.
Who’s affected
Healthcare facilities and medical professionals who own or use the recalled Azurion X-ray systems. The risk is low as the issue involves potential data loss rather than immediate safety hazards.
How to tell if you have this one
Check if your Philips Azurion X-ray system model matches the listed models (3 M12, 3 M15, 5 M12, 5 M20, 7 B12, 7 B20, 7 M12, or 7 M20) with the specific model numbers provided in the recall notice.
- Brand
Philips- Product
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model- Category
Medical device
All 3 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 Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2891-2026 | Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. Interventional Fluoroscopic X-Ray System.; 1. 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(01)00884838054189(21)256, (01)00884838054189(21)336, (01)00884838054189(21)1322, (01)00884838054189(21)853, (01)00884838054189(21)588, (01)00884838054189(21)291, (01)00884838054189(21)743, (01)00884838054189(21)408, (01)00884838054189(21)286, (01)00884838054189(21)1H071046, (01)00884838054189(21)1323, (01)00884838054189(21)1325). 2. Model Number (UDI): 722033 ((01)00884838054233(21)1). 3. Model Numbers (UDI Numbers): 722005 (N/A), 722011 ((01)00884838059047(21)137, (01)00884838059047(21)375, (01)00884838059047(21)256, (01)00884838059047(21)196, (01)00884838059047(21)102, (01)00884838059047(21)140, (01)00884838059047(21)103, (01)00884838059047(21)95, (01)00884838059047(21)107, (01)00884838059047(21)132, (01)00884838059047(21)171, (01)00884838059047(21)362, (01)00884838059047(21)76, (01)00884838059047(21)79, (01)00884838059047(21)267, (01)00884838059047(21)23, (01)00884838059047(21)58, (01)00884838059047(21)33, (01)00884838059047(21)358, (01)00884838059047(21)84, (01)00884838059047(21)319, (01)00884838059047(21)345, (01)00884838059047(21)83, (01)00884838059047(21)15, (01)00884838059047(21)275, (01)00884838059047(21)173, (01)00884838059047(21)205, (01)00884838059047(21)172, (01)00884838059047(21)325, (01)00884838059047(21)169, (01)00884838059047(21)124, (01)00884838059047(21)87, (01)00884838059047(21)155, (01)00884838059047(21)40, (01)00884838059047(21)215, 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(01)00884838059047(21)117, (01)00884838059047(21)153, (01)00884838059047(21)6, (01)00884838059047(21)115, (01)00884838059047(21)129, (01)00884838059047(21)355, (01)00884838059047(21)151, (01)00884838059047(21)91, (01)00884838059047(21)227, (01)00884838059047(21)114, (01)00884838059047(21)274, (01)00884838059047(21)21, (01)00884838059047(21)98, (01)00884838059047(21)230, (01)00884838059047(21)198, (01)00884838059047(21)20, (01)00884838059047(21)160, (01)00884838059047(21)53, (01)00884838059047(21)244, (01)00884838059047(21)92), 722027 ((01)00884838054196(21)332, (01)00884838054196(21)216, (01)00884838054196(21)230, (01)00884838054196(21)1, (01)00884838054196(21)43, (01)00884838054196(21)101, (01)00884838054196(21)50, (01)00884838054196(21)280, (01)00884838054196(21)222, (01)00884838054196(21)41, (01)00884838054196(21)202, (01)00884838054196(21)164, (01)00884838054196(21)288, (01)00884838054196(21)156, (01)00884838054196(21)265, (01)00884838054196(21)152, (01)00884838054196(21)169, 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(01)00884838054196(21)61, (01)00884838054196(21)36, (01)00884838054196(21)294, (01)00884838054196(21)345, (01)00884838054196(21)76, (01)00884838054196(21)94, (01)00884838054196(21)172, (01)00884838054196(21)323, (01)00884838054196(21)324, (01)00884838054196(21)151, (01)00884838054196(21)7, (01)00884838054196(21)99, (01)00884838054196(21)189, (01)00884838054196(21)85, (01)00884838054196(21)102, (01)00884838054196(21)212, (01)00884838054196(21)165, (01)00884838054196(21)126, (01)00884838054196(21)81, (01)00884838054196(21)55, (01)00884838054196(21)6, (01)00884838054196(21)113, (01)00884838054196(21)362, (01)00884838054196(21)259, ( | 5,012 units |
| Z-2892-2026 | Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.; 1. Model Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55), 722221 ((01)00884838099203(21)93, (01)00884838099203(21)108, (01)00884838099203(21)101, (01)00884838099203(21)124, (01)00884838099203(21)4, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)105, (01)00884838099203(21)60, (01)00884838099203(21)33, (01)00884838099203(21)55, (01)00884838099203(21)44, (01)00884838099203(21)74, (01)00884838099203(21)142, (01)00884838099203(21)144, (01)00884838099203(21)147, (01)00884838099203(21)96, (01)00884838099203(21)92, (01)00884838099203(21)78, (01)00884838099203(21)23, (01)00884838099203(21)133, (01)00884838099203(21)167, (01)00884838099203(21)26, (01)00884838099203(21)15, (01)00884838099203(21)163, (01)00884838099203(21)67, (01)00884838099203(21)81, (01)00884838099203(21)22). 2. Model Numbers (UDI Numbers): 722064 ((01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)513, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)479, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)502, (01)00884838085282(21)157, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)264, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)102, (01)00884838085282(21)461, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)185, (01)00884838085282(21)193, (01)00884838085282(21)271, (01)00884838085282(21)214, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)213, 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Model Numbers (UDI Numbers): 722227 ((01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)246, (01)00884838099227(21)84, (01)00884838099227(21)29, (01)00884838099227(21)108, (01)00884838099227(21)62, (01)00884838099227(21)25, (01)00884838099227(21)104, (01)00884838099227(21)109, (01)00884838099227(21)249, (01)00884838099227(21)215, (01)00884838099227(21)167, (01)00884838099227(21)83, (01)00884838099227(21)195, (01)00884838099227(21)116, (01)00884838099227(21)153, (01)00884838099227(21)262, (01)00884838099227(21)113, (01)00884838099227(21)110, (01)00884838099227(21)219, (01)00884838099227(21)256, (01)00884838099227(21)90, (01)00884838099227(21)69, (01)00884838099227(21)200, (01)00884838099227(21)242, (01)00884838099227(21)136, (01)00884838099227(21)137, (01)00884838099227(21)294, (01)00884838099227(21)95, (01)00884838099227(21)165, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)248, (01)00884838099227(21)106, (01)00884838099227(21)26, (01)00884838099227(21)44, (01)00884838099227(21)130, (01)00884838099227(21)58, (01)00884838099227(21)125, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)259, (01)00884838099227(21)131). 4. Model Numbers (UDI Numbers): 722228 ((01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)47, (01)00884838099234(21)87, (01)00884838099234(21)38, (01)00884838099234(21)32, (01)00884838099234(21)25, (01)00884838099234(21)23, (01)00884838099234(21)62, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)431, (01)00884838099234(21)113, (01)00884838099234(21)127, (01)00884838099234(21)91, (01)00884838099234(21)529, (01)00884838099234(21)145, (01)00884838099234(21)539, (01)00884838099234(21)308, (01)00884838099234(21)335, (01)00884838099234(21)333, (01)00884838099234(21)44, (01)00884838099234(21)418, (01)00884838099234(21)525, (01)00884838099234(21)280, (01)00884838099234(21)387, (01)00884838099234(21)471, (01)00884838099234(21)428, (01)00884838099234(21)465, (01)00884838099234(21)103, (01)00884838099234(21)176, (01)00884838099234(21)102, (01)00884838099234(21)178, (01)00884838099234(21)109, 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(01)00884838099234(21)217, (01)00884838099234(21)160, (01)00884838099234(21)82, (01)00884838099234(21)133, (01)00884838099234(21)208, (01)00884838099234(21)165, (01)00884838099234(21)378, (01)00884838099234(21)164, (01)00884838099234(21)228, (01)00884838099234(21)401, (01)00884838099234(21)161, (01)00884838099234(21)147, (01)00884838099234(21)146, (01)00884838099234(21)170, (01)00884838099234(21)295, (01)00884838099234(21)290, (01)00884838099234(21)316, (01)00884838099234(21)207), 722281 ((01)00884838110564(21)55, (01)00884838110564(21)21, (01)00884838110564(21)28, (01)00884838110564(21)27, (01)00884838110564(21)60, (01)00884838110564(21)24, (01)00884838110564(21)48, (01)00884838110564(21)17, (01)00884838110564(21)124, (01)00884838110564(21)64, (01)00884838110564(21)54, (01)00884838110564(21)19, (01)00884838110564(21)26, (01)00884838110564(21)80, (01)00884838110564(21)11, (01)00884838110564(21)9, (01)00884838110564(21)35, (01)00884838110564(21)76, (01)00884838110564(21)294, (01)00884838110564(21)229, (01)00884838110564(21)14, (01)00884838110564(21)33, (01)00884838110564(21)10, (01)00884838110564(21)284, (01)00884838110564(21)57, (01)00884838110564(21)50, (01)00884838110564(21)13, (01)00884838110564(21)34, (01)00884838110564(21)300, (01)00884838110564(21)231, (01)00884838110564(21)75, (01)00884838110564(21)22, (01)00884838110564(21)29, (01)00884838110564(21)31, (01)00884838110564(21)30, (01)00884838110564(21)36). 5. Model Numbers (UDI Numbers): 722067 ((01)00884838085350(21)42, (01)00884838085350(21)221, (01)00884838085350(21)278, (01)00884838085350(21)141, (01)00884838085350(21)133, (01)00884838085350(21)233, (01)00884838085350(21)146, (01)00884838085350(21)256, (01)00884838085350(21)270, (01)00884838085350(21)238, (01)00884838085350(21)187, (01)00884838085350(21)154, (01)00884838085350(21)157, (01)00884838085350(21)251, (01)00884838085350(21)222, (01)00884838085350(21)262, (01)00884838085350(21)29, (01)00884838085350(21)59, (01)00884838085350(21)209, (01)00884838085350(21)260, (01)00884838085350(21)95, (01)00884838085350(21)274, (01)00884838085350(21)218, (01)00884838085350(21)231, (01)00884838085350(21)169, (01)00884838085350(21)275, (01)00884838085350(21)265, (01)00884838085350(21)190, (01)00884838085350(21)203, (01)00884838085350(21)138, (01)00884838085350(21)53, (01)00884838085350(21)140, (01)00884838085350(21)266, (01)00884838085350(21)235, (01)00884838085350(21)272, (01)00884838085350(21)58, (01)00884838085350(21)47, (01)00884838085350(21)273, (01)00884838085350(21)64, (01)00884838085350(21)276, (01)00884838085350(21)232, (01)00884838085350(21)271, (01)00884838085350(21)35, (01)00884838085350(21)207, (01)00884838085350(21)226, (01)00884838085350(21)102, (01)00884838085350(21)105, (01)00884838085350(21)159, (01)00884838085350(21)170, (01)00884838085350(21)193, (01)00884838085350(21)118, (01)00884838085350(21)117, (01)00884838085350(21)85, (01)00884838085350(21)119), 722225 ((01)00884838099265(21)110, (01)00884838099265(21)37, (01)00884838099265(21)157, (01)00884838099265(21)284, (01)00884838099265(21)232, (01)00884838099265(21)230, (01)00884838099265(21)269, (01)00884838099265(21)345, (01)00884838099265(21)296, (01)00884838099265(21)374, (01)00884838099265(21)246, (01)00884838099265(21)128, (01)00884838099265(21)241, (01)00884838099265(21)180, (01)00884838099265(21)367, (01)00884838099265(21)292, (01)00884838099265(21)145, (01)00884838099265(21)306, (01)00884838099265(21)338, (01)00884838099265(21)314, (01)00884838099265(21)83, (01)00884838099265(21)422, (01)00884838099265(21)267, (01)00884838099265(21)223, (01)00884838099265(21)173, (01)00884838099265(21)8, (01)00884838099265(21)301, (01)00884838099265(21)146, (01)00884838099265(21)276, (01)00884838099265(21)109, (01)00884838099265(21)189, (01)00884838099265(21)200, (01)00884838099265(21)372, (01)00884838099265(21)312, (01)00884838099265(21)320, (01)00884838099265(21)393, (01)00884838099265(21)206, (01)00884838099265(21)327, (01)00884838099265(21)96, (01)00884838099265(21)446, (01)00884838099265(21)302, (01)00884838099265(21)242, (01)00884838099265(21)187, (01)00884838099265(21)169, (01)00884838099265(21)135, (01)00884838099265(21)134, (01)00884838099265(21)395, (01)00884838099265(21)116, (01)00884838099265(21)107, (01)00884838099265(21)133, (01)00884838099265(21)313, (01)00884838099265(21)346, (01)00884838099265(21)351, (01)00884838099265(21)349, (01)00884838099265(21)1, (01)00884838099265(21)234, (01)00884838099265(21)218, (01)00884838099265(21)342, (01)00884838099265(21)396, (01)00884838099265(21)348, (01)00884838099265(21)386, (01)00884838099265(21)213, (01)00884838099265(21)125, (01)00884838099265(21)190, (01)00884838099265(21)193, (01)00884838099265(21)341, (01)00884838099265(21)61, (01)00884838099265(21)221, (01)00884838099265(21)154, (01)00884838099265(21)67, (01)00884838099265(21)278, (01)00884838099265(21)162, (01)00884838099265(21)42). 6. Model Numbers (UDI Numbers): 722068 ((01)00884838085367(21)335, (01)00884838085367(21)205, (01)00884838085367(21)494, (01)00884838085367(21)564, (01)00884838085367(21)247, (01)00884838085367(21)85, (01)00884838085367(21)505, (01)00884838085367(21)271, (01)00884838085367(21)443, (01)00884838085367(21)354, (01)00884838085367(21)446, (01)00884838085367(21)73, (01)00884838085367(21)406, (01)00884838085367(21)528, (01)00884838085367(21)350, (01)00884838085367(21)462, (01)00884838085367(21)520, (01)00884838085367(21)469, (01)00884838085367(21)114, (01)00884838085367(21)477, (01)00884838085367(21)107, (01)00884838085367(21)282, (01)00884838085367(21)276, (01)00884838085367(21)608, (01)00884838085367(21)473, (01)00884838085367(21)302, (01)00884838085367(21)126, (01)00884838085367(21)468, (01)00884838085367(21)454, (01)00884838085367(21)410, (01)00884838085367(21)231, (01)00884838085367(21)548, (01)00884838085367(21)495, (01)00884838085367(21)167, (01)00884838085367(21)537, 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| Z-2893-2026 | Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.; Model Number: 722400. 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What to do — step by step
Check Model Numbers
Compare your system's model number with the list of affected models provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
What models are affected by this recall?
The recall affects Philips Azurion 3 M12 (model numbers 722063, 722221), Azurion 3 M15 (722064, 722225, 722226), Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, and Azurion 7 M20 systems.
What should I do if my system is affected?
Contact Philips directly to confirm if your system is affected and follow their instructions for next steps. The recall does not require immediate action but should be checked.
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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-2892-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2892-2026 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.