Allura Xper X-Ray System (Philips) – component missing (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Model Number 72201
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
1. Model Number/System Code (UDI), Serial Numbers: 722003 (No UDI), 292, 314, 1077, 464. 2. Model Number/System Code (UDI), Serial Numbers: 722005 (No UDI), 54. 3. Model Number/System Code (UDI), Serial Numbers: 722006 (No UDI), 2126, 2200, 1560, 1921, 1724, 1219. 4. Model Number/System Code (UDI), Serial Numbers: 722008 (No UDI), 516, 142, 434, 418, 480. 5. Model Number/System Code (UDI), Serial Numbers: 722010 (00884838059030), 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840, 413. 6. Model Number/System Code (UDI), Serial Numbers: 722011 (00884838059047), 308, 344, 243, 266, 231, 286, 369, 378, 259, 333. 7. Model Number/System Code (UDI), Serial Numbers: 722012 (00884838059054), 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667. 8. Model Number/System Code (UDI), Serial Numbers: 722013 (00884838059061), 115, 575, 272, 632, 378, 608, 412, 353, 595, 355, 403. 9. Model Number/System Code (UDI), Serial Numbers: 722023 (00884838059085), 128, 83, 86, 134, 87. 10. Model Number/System Code (UDI), Serial Numbers: 722026 (00884838054189), 233, 561, 942, 368, 826, 1115, 539, 159, 598, 365, 528, 603, 263, 792, 783, 679, 680, 406, 388, 302, 659, 736, 1022, 22, 506, 120, 526. 11. Model Number/System Code (UDI), Serial Numbers: 722027 (00884838054196), 106, 127, 78, 204, 113, 82, 66, 119. 12. Model Number/System Code (UDI), Serial Numbers: 722028 (00884838054202), 668, 265, 1154, 180, 880, 274, 172, 1111, 806, 451, 236, 887, 874, 1266, 1499, 1514, 1457, 908, 1292, 247, 944, 951, 1390, 1662, 415, 105, 1675, 348, 1562, 1029, 51, 941, 403, 427, 659, 935, 1225, 1165, 1621, 725, 723, 1559, 753, 883. 13. Model Number/System Code (UDI), Serial Numbers: 722029 (00884838054219), 69, 58. 14. Model Number/System Code (UDI), Serial Numbers: 722035 (00884838054240), 187, 125, 40, 108, 163, 26, 75, 173, 190, 103. 15. Model Number/System Code (UDI), Serial Numbers: 722038 (00884838054226), 63. 16. Model Number/System Code (UDI), Serial Numbers: 722058 (00884838059115), 238, 161, 84, 39, 133, 244, 193, 187, 102.
Products Sold
1. Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077, 464. 2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI); 54. 3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 2126, 2200, 1560, 1921, 1724, 1219. 4. Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 516, 142, 434, 418, 480. 5. Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840, 413. 6. Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308, 344, 243, 266, 231, 286, 369, 378, 259, 333. 7. Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667. 8. Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 115, 575, 272, 632, 378, 608, 412, 353, 595, 355, 403. 9. Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 128, 83, 86, 134, 87. 10. Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 233, 561, 942, 368, 826, 1115, 539, 159, 598, 365, 528, 603, 263, 792, 783, 679, 680, 406, 388, 302, 659, 736, 1022, 22, 506, 120, 526. 11. Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 106, 127, 78, 204, 113, 82, 66, 119. 12. Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 668, 265, 1154, 180, 880, 274, 172, 1111, 806, 451, 236, 887, 874, 1266, 1499, 1514, 1457, 908, 1292, 247, 944, 951, 1390, 1662, 415, 105, 1675, 348, 1562, 1029, 51, 941, 403, 427, 659, 935, 1225, 1165, 1621, 725, 723, 1559, 753, 883. 13. Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 69, 58. 14. Model Number/System Code (UDI); Serial Numbers: 722035 (00884838054240); 187, 125, 40, 108, 163, 26, 75, 173, 190, 103. 15. Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226); 63. 16. Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 238, 161, 84, 39, 133, 244, 193, 187, 102.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with due to Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Recommended Action
Per FDA guidance
Philips began notifying consignees on about 08/01/2025 via letter. Consignees were instructed to notify all applicable personnel, notify customers if the units have been transferred or distributed, maintain the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, and to complete and return the response form. Philips will be inspecting affected Nehalem Flexvision-2 PCs and installing the air baffle if it is confirmed that this component is missing. Philips expects to start the implementation of this action in affected devices by Q4 2025. Your local Philips representative will contact you to schedule a visit to perform this activity in your system once available.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026