Philips Azurion Systems R3.0 recalled for software issues affecting X-ray imaging
Philips Medical Systems has recalled Azurion Systems R3.0 due to nine software issues that may cause X-ray loss, system restarts, display problems, or imaging misalignment during procedures. These issues could affect image quality and system reliability in clinical use.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Check if your Azurion System model (722229–722236) is running software version R3.0
- Contact Philips Medical Systems immediately for a software update or further instructions
- Do not use the system if you experience X-ray loss, continuous restarts, or imaging problems
- Verify the UDI number on your device matches those listed in the recall notice
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 990 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 4-6, Best, Netherlands
- Classification
- Class II
- Recall number
- Z-1079-2026
In the FDA's words
- Description
- Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234. Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error. Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29. 2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19, (01)00884838116733(21)13, (01)00884838116733(21)15, (01)00884838116733(21)12, (01)00884838116733(21)22. 3. Model Number: 722231. UDI Numbers: (01)00884838116740(21)13, (01)00884838116740(21)29, (01)00884838116740(21)50, (01)00884838116740(21)21, (01)00884838116740(21)19, (01)00884838116740(21)12, (01)00884838116740(21)25, (01)00884838116740(21)4, (01)00884838116740(21)1, (01)00884838116740(21)5, (01)00884838116740(21)2, (01)00884838116740(21)73, (01)00884838116740(21)72, (01)00884838116740(21)75, (01)00884838116740(21)33, (01)00884838116740(21)47, (01)00884838116740(21)60, (01)00884838116740(21)53, (01)00884838116740(21)45, (01)00884838116740(21)61, (01)00884838116740(21)34, (01)00884838116740(21)54, (01)00884838116740(21)35, (01)00884838116740(21)49, (01)00884838116740(21)32, (01)00884838116740(21)28, (01)00884838116740(21)27, (01)00884838116740(21)26, (01)00884838116740(21)51, (01)00884838116740(21)11, (01)00884838116740(21)20, (01)00884838116740(21)41, (01)00884838116740(21)52, (01)00884838116740(21)3. 4. Model Number: 722232. UDI Numbers: (01)00884838116757(21)61, (01)00884838116757(21)60, (01)00884838116757(21)5, (01)00884838116757(21)49, (01)00884838116757(21)2, (01)00884838116757(21)91, (01)00884838116757(21)33, (01)00884838116757(21)34, (01)00884838116757(21)48, (01)00884838116757(21)46, (01)00884838116757(21)23, (01)00884838116757(21)43, (01)00884838116757(21)36, (01)00884838116757(21)96, (01)00884838116757(21)95, (01)00884838116757(21)10, (01)00884838116757(21)76, (01)00884838116757(21)42, (01)00884838116757(21)6, (01)00884838116757(21)77, (01)00884838116757(21)3, (01)00884838116757(21)1, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)44, (01)00884838116757(21)30, (01)00884838116757(21)29, (01)00884838116757(21)28, (01)00884838116757(21)102, (01)00884838116757(21)19, (01)00884838116757(21)8, (01)00884838116757(21)81, (01)00884838116757(21)20, (01)00884838116757(21)16, (01)00884838116757(21)11, (01)00884838116757(21)112, (01)00884838116757(21)63, (01)00884838116757(21)68, (01)00884838116757(21)32, (01)00884838116757(21)35, (01)00884838116757(21)122, (01)00884838116757(21)14, (01)00884838116757(21)82, (01)00884838116757(21)13, (01)00884838116757(21)50, (01)00884838116757(21)57, (01)00884838116757(21)58, (01)00884838116757(21)4, (01)00884838116757(21)105, (01)00884838116757(21)75, (01)00884838116757(21)121, (01)00884838116757(21)120, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)73, (01)00884838116757(21)70, (01)00884838116757(21)69, (01)00884838116757(21)37. 5. Model Number: 722235. UDI Numbers: (01)00884838116788(21)88, (01)00884838116788(21)43, (01)00884838116788(21)12, (01)00884838116788(21)102, (01)00884838116788(21)127, (01)00884838116788(21)57, (01)00884838116788(21)55, (01)00884838116788(21)11, (01)00884838116788(21)76, (01)00884838116788(21)71, (01)00884838116788(21)59, (01)00884838116788(21)77, (01)00884838116788(21)89, (01)00884838116788(21)56, (01)00884838116788(21)99, (01)00884838116788(21)30, (01)00884838116788(21)84, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)93, (01)0088483811
- Hazard
- Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
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