Philips Allura Xper FD10 May Fail to Start Due to BIOS Battery Depletion
Philips is recalling Allura Xper FD10 imaging systems due to faster-than-expected BIOS battery depletion. When depleted, the system will not start, and no warning appears before battery failure.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The hazard is a functional failure caused by battery depletion, not a direct safety threat. This is a precautionary recall addressing a design defect.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10 imaging system (model numbers 722003, 722010, 722026) distributed worldwide, including in the United States. Approximately 2,317 units are affected, with 497 distributed in the US.
The BIOS battery in affected units depletes faster than anticipated during the design phase. When the battery becomes depleted, the system fails to start and will not initialize. Users receive no warning message before the battery level is low or fully depleted.
Healthcare facilities using affected Allura Xper FD10 systems should contact Philips Medical Systems Nederland B.V. immediately for replacement or repair options. Facilities should verify their equipment serial numbers against the recall list.
The recalled product
- Product
- Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Medical Imaging
- Hazard
- battery-depletion
- startup-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Numbers: (1) 722003
- (2) 722010
- (3) 722026
- UDI-DI: (1) N/A
- (2) 00884838059030
- (3) 00884838054189
- Serial Numbers: (1) 1343
- 1349
- 1153
- 1154
- 1472
- 257
- 1694
- 746
- 745
- 1599
- 501
- 503
- 1360
- 959
Distribution
Distributed nationwide across the United States.
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