Allura Xper FD recallZ-2626-2025 · Philips Medical Systems Nederland B.V. · initiated Sep 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
FDA root cause category: Device Design
What the company is doing
On September 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. "Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue and follow the instructions included in the letter. 2. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 4. Complete and return the response form included in this Urgent Medical Device Correction to Philips promptly and no later than 30 days from receipt. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions Planned by Recalling Firm: 1. Philips will be replacing the Geo PC in all affected systems. 2. Philips expects to start replacing the Geo PC units by September 2025. Your local Philips representative will contact you to schedule a visit to confirm if your system has a model Wolfdale (Q35 generation) Geo PC and to plan the replacement of the Geo PC once available. 3. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Recall details
- Recall number
- Z-2626-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 3, 2025
- Posted by the FDA
- Sep 25, 2025
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 2114 units (791 US, 1323 OUS)
- Product code
- OWB
- FDA submissions
- K102005, K130638, K130842, K133292, K141979, K161563
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Product description
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Code information (models, lots, serial numbers)
Show the full code information (12k characters)
Product Codes: (1)722012, (2) 722028, (3) 722006; UDI-DI: (1) 00884838059054, (2) 00884838054202, (3) N/A; Serial numbers: (1) 919, 1581, 1117, 1001, 1673, 1712, 585, 517, 1545, 1715, 504, 757, 935, 1356, 1250, 1613, 2006, 1440, 1550, 1733, 1734, 2201, 1922, 741, 2283, 1034, 1359, 1848, 950, 2943, 865, 1908, 1166, 1113, 1804, 100, 1408, 590, 2508, 1279, 2509, 452, 2151, 1724, 2134, 481, 543, 893, 1455, 2085, 423, 1282, 2307, 1798, 1656, 990, 1806, 1871, 2506, 1652, 894, 2920, 1189, 1099, 1038, 1058, 566, 823, 1037, 924, 2319, 2310, 1610, 686, 2933, 2514, 1108, 500, 459, 1422, 1035, 84, 1649, 1895, 1900, 1723, 878, 2221, 464, 2496, 2222, 1515, 1731, 1017, 1020, 380, 1811, 527, 2171, 418, 1053, 1558, 1336, 601, 1014, 1265, 331, 389, 732, 751, 1324, 2276, 684, 2219, 814, 815, 1120, 297, 1713, 580, 1098, 1852, 1307, 1858, 758, 2054, 856, 1690, 1407, 480, 579, 1327, 695, 733, 1506, 1091, 1254, 797, 213, 1280, 828, 1118, 1249, 542, 1033, 2265, 490, 920, 1209, 470, 1075, 2203, 1396, 444, 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Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System25 recalls2 deaths3,984 reports
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths3,614 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97501).
- Z-2623-2025 · Open, ClassifiedAllura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2624-2025 · Open, ClassifiedAllura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2625-2025 · Open, ClassifiedAllura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2627-2025 · Open, ClassifiedAllura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2628-2025 · Open, ClassifiedAllura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K0419…
- Z-2629-2025 · Open, ClassifiedAllura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2630-2025 · Open, ClassifiedAllura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2631-2025 · Open, ClassifiedAllura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2632-2025 · Open, ClassifiedAllura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2633-2025 · Open, ClassifiedAllura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Z-2634-2025 · Open, ClassifiedAllura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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