Philips Allura Xper systems recalled for unauthorized hard drives
Philips Medical Systems Nederland B.V. is recalling certain Allura Xper interventional fluoroscopic X-ray systems because unauthorized hard disk drives may be installed. The notice says this could cause a loss of imaging, a loss of motorized movement, or a loss of data. About 5,012 units are affected, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Contact Philips Medical Systems Nederland B.V. to confirm whether your system is affected and how to proceed; the notice doesn't specify a remedy.
- Check each system's model number against the list in the notice, such as 722001, 722003, and 722010, and note any matches.
- Share this recall with your biomedical engineering or clinical staff so affected systems can be identified.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 5,012 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 6, Best, Netherlands
- Classification
- Class II
- Recall number
- Z-2891-2026
In the FDA's words
- Description
- 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. Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. 1. Allura Xper FD10; Model Numbers (UDI Numbers): 722003 (N/A), 722010 ((01)00884838059030(21)754, (01)00884838059030(21)42, (01)00884838059030(21)500, (01)00884838059030(21)68, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)585, (01)00884838059030(21)641, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)667, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)359, (01)00884838059030(21)423, (01)00884838059030(21)1040, (01)00884838059030(21)478, (01)00884838059030(21)215, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)365, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)61, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)00884838059030(21)327, (01)00884838059030(21)65, (01)00884838059030(21)1369, (01)00884838059030(21)792, (01)00884838059030(21)679, (01)00884838059030(21)479, (01)00884838059030(21)485, (01)00884838059030(21)592, (01)00884838059030(21)229, (01)00884838059030(21)119, (01)00884838059030(21)662, (01)00884838059030(21)1235, (01)00884838059030(21)1214, (01)00884838059030(21)764, (01)00884838059030(21)902, (01)00884838059030(21)1344, (01)00884838059030(21)675, (01)00884838059030(21)191, (01)00884838059030(21)937, (01)00884838059030(21)1432, (01)00884838059030(21)308, (01)00884838059030(21)833, (01)00884838059030(21)1310, (01)00884838059030(21)728, (01)00884838059030(21)791, (01)00884838059030(21)987, (01)00884838059030(21)986, (01)00884838059030(21)1005, (01)00884838059030(21)1425, (01)00884838059030(21)965, (01)00884838059030(21)1132, (01)00884838059030(21)468, (01)00884838059030(21)527, (01)00884838059030(21)1442, (01)00884838059030(21)646, (01)00884838059030(21)648, (01)00884838059030(21)873, (01)00884838059030(21)274, (01)00884838059030(21)1391, (01)00884838059030(21)838, (01)00884838059030(21)999, (01)00884838059030(21)821, (01)00884838059030(21)170, (01)00884838059030(21)673, (01)00884838059030(21)683, (01)00884838059030(21)637, (01)00884838059030(21)784, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)638, (01)00884838059030(21)1112, (01)00884838059030(21)1373, (01)00884838059030(21)878, (01)00884838059030(21)1108, (01)00884838059030(21)830, (01)00884838059030(21)40, (01)00884838059030(21)39, (01)00884838059030(21)777, (01)00884838059030(21)608, (01)00884838059030(21)1260, (01)00884838059030(21)1052, (01)00884838059030(21)339, (01)00884838059030(21)447, (01)00884838059030(21)1250, (01)00884838059030(21)1147, (01)00884838059030(21)1034, (01)00884838059030(21)1421, (01)00884838059030(21)1258, (01)00884838059030(21)484, (01)00884838059030(21)626, (01)00884838059030(21)1332, (01)00884838059030(21)534, (01)00884838059030(21)868, (01)00884838059030(21)782, (01)00884838059030(21)985, (01)00884838059030(21)697, (01)00884838059030(21)707, (01)00884838059030(21)708, (01)00884838059030(21)1146, (01)00884838059030(21)1267, (01)00884838059030(21)891, (01)00884838059030(21)566, (01)00884838059030(21)569, (01)00884838059030(21)861, (01)00884838059030(21)1321, (01)00884838059030(21)1096, (01)00884838059030(21)906, (01)00884838059030(21)1366, (01)00884838059030(21)661, (01)00884838059030(21)872, (01)00884838059030(21)374, (01)00884838059030(21)243, (01)00884838059030(21)1428, (01)00884838059030(21)225, (01)00884838059030(21)812, (01)00884838059030(21)857, (01)00884838059030(21)1274, (01)00884838059030(21)598, (01)00884838059030(21)555, (01)00884838059030(21)844, (01)00884838059030(21)1285, (01)00884838059030(21)969, (01)00884838059030(21)1046, (01)00884838059030(21)1045, (01)00884838059030(21)31, (01)00884838059030(21)139, (01)008848
- Hazard
- Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
3 products in this recall
Philips Allura, Azurion X-ray systems recalled for hard drive risk
Philips is recalling 3 interventional X-ray system lines, sold as Philips Allura (including Allura Xper FD10 and Allura Centron), Philips Azurion, and Allura Centron, with about 8,610 units affected. The systems may contain unauthorized hard disk drives, which could cause loss of imaging, loss of motorized movement, or loss of data. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Al… (this page)Z-2891-2026 · 5,012 units
- Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M1…Z-2892-2026 · 3,341 units
- Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.Z-2893-2026 · 257 units
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