Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: 722058; UDI-DI: 00884838059115; Serial numbers: 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109, 100, 124, 94, 23, 111, 110, 108, 32, 161, 89, 18, 19, 409, 66, 55, 40, 72, 15, 9, 25, 81, 119, 60, 164, 7, 101, 106, 145, 136, 137, 76, 112, 130, 45, 144, 64, 79, 29, 21, 16, 10, 90, 70, 153, 34, 43, 31, 75, 20, 63, 117, 73, 116, 148, 95, 68, 139, 67, 93, 354, 58, 115, 154, 92, 142, 256, 128, 141, 78, 183, 125, 126, 143, 170, 30, 11, 127, 27, 97, 48;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Product Codes/Lot Numbers:
Product Code: 722058; UDI-DI: 00884838059115; Serial numbers: 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109, 100, 124, 94, 23, 111, 110, 108, 32, 161, 89, 18, 19, 409, 66, 55, 40, 72, 15, 9, 25, 81, 119, 60, 164, 7, 101, 106, 145, 136, 137, 76, 112, 130, 45, 144, 64, 79, 29, 21, 16, 10, 90, 70, 153, 34, 43, 31, 75, 20, 63, 117, 73, 116, 148, 95, 68, 139, 67, 93, 354, 58, 115, 154, 92, 142, 256, 128, 141, 78, 183, 125, 126, 143, 170, 30, 11, 127, 27, 97, 48;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2633-2025
Related Recalls
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.