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: 7
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The hazard
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Allura Xper FD10Model Model Numbers (UDI Numbers): 722003 (N/A)Model 722010 ((01)00884838059030(21)754Model (01)00884838059030(21)42Model (01)00884838059030(21)500Model (01)00884838059030(21)68Model (01)00884838059030(21)521Model (01)00884838059030(21)33Model (01)00884838059030(21)1025Model (01)00884838059030(21)668Model (01)00884838059030(21)585Model (01)00884838059030(21)641Model (01)00884838059030(21)968Model (01)00884838059030(21)890Model (01)00884838059030(21)780Model (01)00884838059030(21)667Model (01)00884838059030(21)1279Model (01)00884838059030(21)344Model (01)00884838059030(21)359Model (01)00884838059030(21)423Model (01)00884838059030(21)1040Model (01)00884838059030(21)478Model (01)00884838059030(21)215Model (01)00884838059030(21)1298Model (01)00884838059030(21)970UPC 00884838059030Would you have heard about this one?
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