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Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following w...

FDA Recall #Z-2504-2025 — Class II — August 1, 2025

Recall #Z-2504-2025 Date: August 1, 2025 Classification: Class II Status: Ongoing

Product Description

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.

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.

Recalling Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

192 untis

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.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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