Allura Xper FD20/20 Operating Room Table Battery Issue Affects Startup
Philips recalled 5 Allura Xper FD20/20 OR tables because the BIOS battery depletes faster than designed, preventing the system from starting. No user warnings appear before the battery fails.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with no reported injuries to date. The BIOS battery defect prevents the operating room table from starting, which could compromise surgical procedures. The lack of advance warning messages compounds the risk by preventing operators from anticipating the failure.
Plain-English summary
Philips Medical Systems recalled 5 Allura Xper FD20/20 operating room tables due to a BIOS battery that depletes faster than anticipated during the device design phase. When the battery is fully depleted, the system's startup process stops and the equipment cannot start.
The device does not display any user messages to alert operators before the battery becomes low or completely depleted, meaning operators may not be aware of the battery condition until the device fails to start.
The affected units are Model Number 722039, serial numbers 2, 4, 5, 6, and 8. These devices have been distributed worldwide.
Users should contact Philips Medical Systems Nederland B.V. for information about remediation options.
The recalled product
- Product
- Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-depletion
- startup-failure
- missing-warning
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 (7)
- Model Numbers: 722039
- UDI-DI: 00884838054271
- Serial Numbers: 2
- 4
- 5
- 6
- 8
Distribution
Distributed nationwide across the United States.
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