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 722013. 9. Allura Xper FD20 OR Table, Model Number 722023. 10. Allura Xper FD10, Model Number 722026. 11. Allura Xper FD10/10, Model Number 722027. 12. Allura Xper FD20, Model Number 722028. 13. Allura Xper FD20/10, Model Number 722029. 14. Allura Xper FD20 OR Table, Model Number 722035. 15. Allura Xper FD20/20, Model Number 722038. 16. Allura Xper FD20/15, Model Number 722058. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.
This recall is currently active, issued September 3, 2025. It was issued by Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best Netherlands.
- Recall Initiated
- August 1, 2025
- Posted
- September 3, 2025
- Recall Number
- Z-2504-2025
- Quantity
- 192 untis
- Official Source
- View on FDA website ↗
Reason for Recall
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Distribution
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium, Switzerland, Chile, China, Colombia, Czechia, Germany, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, India, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Norway, Oman, Pakistan, Poland, Romania, Saudi Arabia, Sweden, Singapore, Thailand, Vietnam.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
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.