FDA Medical devices recall · September 10, 2025

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series recall

Read the official FDA notice ↗

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 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.

Why was it recalled?

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot 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);

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.

States: Alabama Arizona California District of Columbia Florida Georgia Hawaii Idaho Illinois Kansas Kentucky Louisiana Michigan Minnesota Missouri North Carolina New Jersey New Mexico Nevada New York Ohio Oregon Pennsylvania Tennessee Texas Utah Virginia Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2504-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.