PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Product Codes: (1)722012
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Lot / code information
- UDI
- (1) 00884838059054, (2) 00884838054202, (3) N/A
- Serial #
(1) 919, 1581, 1117, 1001, 1673, 1712 — +2108 moreShow all
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630, 1825, 1839, 1591, 2462, 502, 2599, 98, 1196, 1495, 2139, 2490, 477, 2204, 779, 2558, 2385, 770, 799, 1703, 2178, 541, 1480, 2553, 2545, 608, 2356, 1297, 2026, 652, 1150, 1349, 911, 2585, 871, 1678, 2451, 2413, 2076, 2127, 1671, 1081, 1028, 2056, 1708, 830, 2479, 1978, 2363, 2102, 663, 2474, 839, 2298, 1151, 1152, 1626, 2403, 1882, 569, 688, 2016, 2434, 1366, 2296, 544, 1481, 1390, 419, 2504, 2197, 1436, 2336, 728, 785, 355, 1698, 793, 794, 1556, 1654, 2539, 1736, 2601, 2604, 1967, 622, 1691, 2365, 2366, 2291, 2299, 2501, 1669, 2634, 1471, 737, 1879, 581, 2121, 1937, 2388, 2180, 1342, 647, 867, 1288, 1489, 1178, 1874, 2175, 479, 2537, 1237, 1381, 2274, 398, 2523, 2491, 2459, 1965, 1818, 941, 1147, 803, 1699, 798, 441, 1089, 2429, 1463, 1479, 534, 1138, 2401, 752, 2344, 1536, 2249, 2532, 2410, 772, 1021, 1382, 2441, 2326, 2345, 1999, 2405, 1309, 2438, 1572, 2173, 2174, 1836, 2549, 2583, 730, 2031, 1976, 2118, 1079, 1530, 1875, 593, 2394, 2527, 1412, 1548, 2384, 2153, 748, 2576, 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1534, 1813 …
What the firm 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).
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2626-2025
- FDA 510(k) clearance · K102005The device's official FDA premarket clearance record
- FDA 510(k) clearance · K130638The device's official FDA premarket clearance record
- FDA 510(k) clearance · K130842The device's official FDA premarket clearance record
- FDA 510(k) clearance · K133292The device's official FDA premarket clearance record
- FDA 510(k) clearance · K141979The device's official FDA premarket clearance record
- FDA 510(k) clearance · K161563The device's official FDA premarket clearance record
- FDA device classification · OWBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1650The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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