Philips Allura Xper systems recalled for FlexVision software issue
Philips Medical Systems Nederland B.V. is recalling Allura Xper systems running software releases R8.1.x or R8.2.x that are configured with a FlexVision monitor. The software issue may cause the FlexVision software application to become unresponsive during clinical use.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Contact Philips for instructions before continuing to use an affected system in clinical procedures.
- Affected systems are Allura Xper FD10, FD10/10, FD20, and FD20 Biplane models, plus related OR table configurations, with model numbers such as 722003, 722010, 722026, 722033, 722005, and 722006.
- Check the system's software release and serial or UDI numbers against the full list in the notice.
- The notice does not specify a remedy; contact Philips for how to get the software issue corrected.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips Allura Xper systems with software releases R8.1.x and R8.2.x systems and configured with a FlexVision monitor. Includes the following System Product Names 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 FD20; Model Numbers: 722006, 722012, 722028. 5. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 6. ALLURA XPER FD20 BIPLANE OR TABLE; Model Number: 722025. 7. Allura Xper FD20 OR Table; Model Numbers: 722023, 722035. 8. Allura Xper FD20/10; Model Number: 722029. 9. Allura Xper FD20/15; Model Number: 722058. 10. Allura Xper FD20/15 OR Table; Model Number: 722059. 11. Allura Xper FD20/20; Model Number: 722038. 12. Allura Xper FD20/20 OR Table; Model Number: 722039. 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K161563, K162859.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 3,363 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 6, Best, Netherlands
- Classification
- Class II
- Recall number
- Z-0367-2027
In the FDA's words
- Description
- Philips Allura Xper systems with software releases R8.1.x and R8.2.x systems and configured with a FlexVision monitor. Includes the following System Product Names 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 FD20; Model Numbers: 722006, 722012, 722028. 5. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 6. ALLURA XPER FD20 BIPLANE OR TABLE; Model Number: 722025. 7. Allura Xper FD20 OR Table; Model Numbers: 722023, 722035. 8. Allura Xper FD20/10; Model Number: 722029. 9. Allura Xper FD20/15; Model Number: 722058. 10. Allura Xper FD20/15 OR Table; Model Number: 722059. 11. Allura Xper FD20/20; Model Number: 722038. 12. Allura Xper FD20/20 OR Table; Model Number: 722039. 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K161563, K162859. Software issue that may cause the FlexVision software application to become unresponsive during clinical use. 1. Allura Xper FD10; Model Number: 722003 (UDI Numbers: N/A); Serial Numbers: 475, 469, 1544, 729, 1585, 1338, 1641, 1563, 492, 505, 1516, CV.719, 1017, 313, 314, 1176, 1230, 1925, 596, 464, 796, 1928, 292, 500, 1, 1918, 961, 1172, 354, 363, 1637, 445, 1788, 485, 928, 345, 390, 472, 1349, 1594, 1311, 1187, 1700, 368, 912, 913, 940, 467, 285. Model Number: 722010 (UDI Numbers: (01)00884838059030(21)1034, (01)00884838059030(21)1016, (01)00884838059030(21)1017, (01)00884838059030(21)1018, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)868, (01)00884838059030(21)985, (01)00884838059030(21)374, (01)00884838059030(21)524, (01)00884838059030(21)31, (01)00884838059030(21)578, (01)00884838059030(21)1185, (01)00884838059030(21)58, (01)00884838059030(21)786, (01)00884838059030(21)126, (01)00884838059030(21)1166, (01)00884838059030(21)884, (01)00884838059030(21)254, (01)00884838059030(21)62, (01)00884838059030(21)1385, (01)00884838059030(21)1216, (01)00884838059030(21)740, (01)00884838059030(21)828, (01)00884838059030(21)1192, (01)00884838059030(21)1095, (01)00884838059030(21)373, (01)00884838059030(21)875, (01)00884838059030(21)1117, (01)00884838059030(21)313, (01)00884838059030(21)900, (01)00884838059030(21)907, (01)00884838059030(21)1439, (01)00884838059030(21)29, (01)00884838059030(21)63, (01)00884838059030(21)762, (01)00884838059030(21)50, (01)00884838059030(21)1152, (01)00884838059030(21)770, (01)00884838059030(21)817, (01)00884838059030(21)165, (01)00884838059030(21)1429, (01)00884838059030(21)1430, (01)00884838059030(21)418, (01)00884838059030(21)781, (01)00884838059030(21)720, (01)00884838059030(21)186, (01)00884838059030(21)719, (01)00884838059030(21)64, (01)00884838059030(21)940, (01)00884838059030(21)1056, (01)00884838059030(21)1212, (01)00884838059030(21)909, (01)00884838059030(21)548, (01)00884838059030(21)1393, (01)00884838059030(21)267, (01)00884838059030(21)1036, (01)00884838059030(21)560, (01)00884838059030(21)115, (01)00884838059030(21)533, (01)00884838059030(21)498, (01)00884838059030(21)1402, (01)00884838059030(21)1088, (01)00884838059030(21)347, (01)00884838059030(21)1265, (01)00884838059030(21)1177, (01)00884838059030(21)744, (01)00884838059030(21)20, (01)00884838059030(21)1434, (01)00884838059030(21)189, (01)00884838059030(21)1051, (01)00884838059030(21)1194, (01)00884838059030(21)885, (01)00884838059030(21)707, (01)00884838059030(21)748, (01)00884838059030(21)1163, (01)00884838059030(21)1164, (01)00884838059030(21)1378, (01)00884838059030(21)1390, (01)00884838059030(21)1394, (01)00884838059030(21)706, (01)00884838059030(21)1165, (01)00884838059030(21)1032, (01)00884838059030(21)1191, (01)00884838059030(21)340, (01)00884838059030(21)841, (01)00884838059030(21)765, (01)00884838059030(21)1445, (01)00884838059030(21)1242, (01)00884838059030(21)104, (01)00884838059030(21)1401, (01)00884838059030(21)621, (01)00884838059030(21)371, (01)00884838059030(21)1022, (01)00884838059030(21)1435, (01)00884838059030(21)742, (01)00884838059030(21)1029, (01)00884838059030(21)1268, (01)00884838059030(21)1145, (01)00884838059030(21)357, (01)00884838059030(21)287, (01)00884838059030(21)1104, (01)00884838059030(21)887, (01)00884838059030(21)998, (01)00884838059030(21)834, (01)00884838059030(21)1091, (01)00884838059030(21)1030, (01)00884838059030(21)1031, (01)00884838059030(21)182, (01)00884838059030(21)1159, (01)00884838059030(21)1182, (01)00884838059030(21)1433, (01)00884838059030(21)1131, (01)00884838059030(21)631, (01)00884838059030(21)1303, (01)00884838059030(21)804, (01)00884838059030(21)1044, (01)00884838059030(21)880, (01)00884838059030(21)1280, (01)00884838059030(21)858, (01)00884838059030(21)362, (01)00884838059030(21)1207, (01)00884838059030(21)874, (01)00884838059030(21)1218, (01)00884838059030(21)934, (01)00884838059030(21)855, (01)00884838059030(21)583, (01)00884838059030(21)777, (01)00884838059030(21)608, (01)0088
- Hazard
- Software issue that may cause the FlexVision software application to become unresponsive during clinical use.
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