Philips Allura Xper FD10/10 fluoroscopy systems unable to start due to battery failure
The BIOS battery in affected Philips Allura Xper FD10/10 fluoroscopy systems may deplete faster than expected, preventing system startup. No warning messages alert users before the battery runs low.
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 recall with no reported illnesses, injuries, or deaths. The hazard is device non-functionality (BIOS battery depletion preventing startup) rather than direct patient harm. This is a precautionary operational failure recall.
Plain-English summary
Philips Medical Systems has recalled the Allura Xper FD10/10 fluoroscopy system (model numbers 722005, 722011, and 722027). This Class II recall affects 585 units: 145 distributed in the United States and 440 internationally.
The internal BIOS battery in affected systems may deplete faster than anticipated during the design phase. When fully depleted, the system cannot start. No warning messages are displayed before the battery runs low or becomes depleted, leaving operators without advance notice.
Healthcare facilities with these systems should contact Philips Medical Systems Nederland B.V. immediately for instructions on battery replacement and system servicing. The system should not be operated without confirming the BIOS battery status and implementing necessary repairs.
The recalled product
- Product
- Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- startup-failure
- battery-depletion
- missing-warning-message
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) 722005
- (2) 722011
- (3) 722027
- UDI-DI: (1) N/A
- (2) 00884838059047
- (3) 00884838054196
- Serial Numbers: (1) 361
- 212
- 233
- 321
- 435
- 285
- 384
- 388
- 343
- 399
- 392
- 128
- 355
- 51
Distribution
Distributed nationwide across the United States.
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