Recall archive / FDA device enforcement
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1... — FDA record Z-2624-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 286 units (67 US, 219 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2624-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Codes: (1)722011, (2) 722027, (3) 722005; UDI-DI: (1) 00884838059047, (2) 00884838054196, (3) N/A; Serial numbers: (1) 157, 268, 95, 107, 59, 319, 49, 170, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 87, 255, 171, 362, 168, 275, 344, 324, 163, 103, 215, 328, 286, 81, 293, 294, 224, 117, 334, 338, 146, 145, 266, 21, 202, 165, 367, 372, 340, 318, 98, 211, 158, 271, 204, 246, 206, 321, 295, 104, 217, 265, 261, 125, 282, 216, 333, 329, 230, 198, 244, 292, 180, 183, 314, 337, 341, 376, 377, 378, 259, 347, 287, 99, 233, 156, 71, 77, 188, 223, 238, 153, 129, 278, 118, 186, 108, 89, 258, 310, 274, 139, 141, 86, 300, 88, 309, 227, 220, 242, 166, 299, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 116, 112, 114, 43, 313, (2) 123, 133, 134, 183, 106, 169, 107, 42, 101, 209, 153, 40, 156, 112, 1, 104, 71, 175, 116, 174, 29, 50, 56, 152, 43, 49, 202, 178, 127, 39, 27, 64, 78, 99, 6, 86, 7, 145, 102, 44, 142, 30, 79, 38, 85, 181, 144, 177, 165, 201, 3, 68, 51, 21, 23, 24, 90, 171, 45, 122, 33, 137, 163, 150, 96, 155, 20, 166, 147, 139, 91, 136, 193, 69, 65, 168, 206, 158, 66, 75, 62, 138, 121, 18, 31, 131, 195, 192, 125, 148, 149, 46, 47, 135, 159, 100, 103, 110, 57, 274, 61, 36, 151, 300, 167, 60, 81, 126, 58, 184, 5, 188, 94, 154, 172, 35, 76, 95, 187, 170, 146, 162, 82, 117, 48, 205, 182, 132, (3) 212, 435, 128, 323, 269, 342, 531, 403, 287, 457, 373, 332, 374, 428, 75, 499, 511, 473, TPE, 333, 237, 338, SN545, 159, 100071298SN408, 96; |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 1, 2025
- Recall initiation date
- Sep 3, 2025
- Center classification date
- Sep 25, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.