FDAFDA · Food and drugs·Recall number Z-2891-2026

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.

Published August 12, 2026 · Recall initiated: June 17, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distributor: US Nationwide distribution.
Lot: 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)00884838059030(21)928, (01)00884838059030(21)578, (01)00884838059030(21)1185, (01)00884838059030(21)28, (01)00
Risk classification: Class II
Area (FDA): device
Country: Netherlands

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card