Philips Azurion X-ray systems recalled over image and movement software issues
Philips is recalling certain Azurion interventional fluoroscopic X-ray systems running software version R2.2.10. The software can degrade image quality or cause a loss of geometry movements, which may delay treatment or lead to procedural complications. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Hospitals and clinical users should contact Philips for the software correction or instructions.
- Check the recall notice for the affected model numbers and software versions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 10872 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 6, Best, Netherlands
- Classification
- Class II
- Recall number
- Z-2931-2026
In the FDA's words
- Description
- Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications UDI: (01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578, (01)00884838099241(21)324, (01)00884838099241(21)585, (01)00884838099241(21)332, (01)00884838099258(21)750, (01)00884838099241(21)312, (01)00884838099241(21)85, (01)00884838099258(21)409, (01)00884838085268(21)1023, (01)00884838099272(21)125, (01)00884838099272(21)127, (01)00884838099272(21)126, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099258(21)295, (01)00884838099272(21)124, (01)00884838099272(21)120, (01)00884838099258(21)277, (01)00884838099258(21)262, (01)00884838099258(21)261, (01)00884838099258(21)272, (01)00884838099258(21)275, (01)00884838085367(21)547, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838085251(21)585, (01)00884838099258(21)1315, (01)00884838085268(21)645, (01)00884838085251(21)410, (01)00884838085268(21)646, (01)00884838099258(21)3526, (01)00884838099258(21)2744, (01)00884838099258(21)3698, (01)00884838099258(21)959, (01)00884838099258(21)381, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838099258(21)1371, (01)00884838099241(21)533, (01)00884838085268(21)1387, (01)00884838099272(21)153, (01)00884838099258(21)1019, (01)00884838085268(21)460, (01)00884838099258(21)260, (01)00884838085251(21)753, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838099272(21)67, (01)00884838099258(21)1049, (01)00884838099258(21)3045, (01)00884838099258(21)3044, (01)00884838099258(21)3107, (01)00884838099258(21)2258, (01)00884838099258(21)1484, (01)00884838099272(21)209, (01)00884838099258(21)2573, (01)00884838099258(21)3514, (01)00884838099258(21)1083, (01)00884838099258(21)3314, (01)00884838085268(21)703307, (01)00884838099258(21)2436, (01)00884838099258(21)2184, (01)00884838099241(21)479, (01)00884838099272(21)271, (01)00884838099241(21)189, (01)00884838099258(21)246, (01)00884838085251(21)523, (01)00884838099241(21)1038, (01)00884838099241(21)47, (01)00884838099258(21)475, (01)00884838099241(21)1146, (01)00884838085268(21)703904, (01)00884838099258(21)1810, (01)00884838085268(21)890, (01)00884838099265(21)104, (01)00884838099258(21)762, (01)00884838099258(21)3153, (01)00884838085251(21)840, (01)00884838085251(21)293, (01)00884838099258(21)526, (01)00884838099258(21)2241, (01)00884838099258(21)588, (01)00884838099258(21)469, (01)00884838099272(21)675, (01)00884838099258(21)962, (01)00884838085268(21)1137, (01)00884838085268(21)1048, (01)00884838099241(21)352, (01)00884838099258(21)539, (01)00884838085350(21)221, (01)00884838099258(21)421, (01)00884838085350(21)42, (01)00884838085350(21)172, (01)00884838085350(21)173, (01)00884838099258(21)288, (01)00884838085268(21)401, (01)00884838099265(21)153, (01)00884838099241(21)391, (01)00884838085367(21)467, (01)00884838099272(21)112, (01)00884838099258(21)90, (01)00884838085268(21)1054, (01)00884838085268(21)1010, (01)00884838085367(21)178, (01)00884838085268(21)536, (01)00884838085268(21)534, (01)00884838085268(21)535, (01)00884838085268(21)266, (01)00884838099258(21)2784, (01)00884838099258(21)1635, (01)00884838085367(21)335, (01)00884838099258(21)50, (01)00884838085282(21)209, (01)00884838085251(21)291, (01)00884838099258(21)239, (01)00884838099258(21)2520, (01)00884838099258(21)589, (01)00884838085268(21)818, (01)00884838099258(21)91, (01)00884838099210(21)332, (01)00884838085268(21)412, (01)00884838099258(21)2945, (01)00884838099258(21)1556, (01)00884838099258(21)840, (01)00884838085268(21)617, (01)00884838099241(21)328, (01)00884838099258(21)362, (01)00884838099258(21)43, (01)00884838099258(21)1869, (01)00884838099241(21)681, (01)00884838099272(21)1091, (01)00884838099272(21)1052, (01)00884838099258(21)1564, (01)00884838085268(21)246, (01)00884838085268(21)488, (01)00884838085268(21)53, (01)00884838085268(21)57, (01)00884838099258(21)1692, (01)00884838085268(21)905, (01)00884838085367(21)147, (01)00884838099258(21)2778, (01)00884838085268(21)55, (01)00884838099258(21)44, (01)00884838099258(21)210, (01)00884838085268(21)992, (01)00884838085268(21)691, (01)00884838099258(21)2421, (01)00884838099258(21)2432, (01)00884838099258(21)287, (01)00884838099272(21)113, (01)00884838085268(21)848, (01)0
- Hazard
- Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
More from Philips
See all- Philips Allura Xper systems recalled for FlexVision software issue
ModerateFDANov 6, 2026
- Philips Azurion 3 M12 systems recalled over unapproved drives
ModerateFDAOct 27, 2026
- Philips Azurion X-ray systems recalled for software image and movement issues
ModerateFDAAug 19, 2026
- Philips Allura Xper FD X-ray systems recalled over firmware issue
ModerateFDAAug 19, 2026