Operating Room Table Battery May Prevent System Startup
Philips Allura Xper FD20 operating room tables have BIOS batteries that may deplete faster than designed, preventing system startup without user warning.
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 recall with no reported injuries or hospitalizations. The hazard is operational equipment failure due to faster-than-expected battery depletion, without direct patient safety implications.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20 operating room table (Models 722015, 722023, and 722035) due to a BIOS battery that depletes faster than expected during the design phase. When the battery is fully depleted, the system cannot start up properly.
The system provides no warning messages to users before the battery becomes low or depleted. This means operators may attempt to use the equipment without knowing the battery has failed, resulting in unexpected system shutdown at startup.
This recall affects 298 units worldwide, including 72 units in the United States. The affected equipment was distributed across numerous countries for use in hospitals and medical facilities.
Users should contact Philips Medical Systems Nederland B.V. for instructions on addressing the BIOS battery issue. Affected facilities should verify the battery status of their equipment and follow manufacturer guidance to prevent unexpected failures.
The recalled product
- Product
- Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-depletion
- system-startup-failure
- equipment-malfunction
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) 722015
- (2) 722023
- (3) 722035
- UDI-DI: (1) N/A
- (2) 00884838059085
- (3) 00884838054240
- Serial Numbers: (1) 12
- 2
- 16
- 8
- 23
- 3
- 13
- (2) 27
- 116
- 12
- 175
- 98
- 35
- 72
Distribution
Distributed nationwide across the United States.
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