Operating Room Table BIOS Battery Depletes, Preventing System Startup
The Allura Xper FD10 OR Table may experience faster-than-expected BIOS battery depletion without warning, preventing system startup.
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 FDA Class II recall affecting a risk-of-harm medical device (operating room table) with no reported injuries or illnesses. The functional failure poses potential risk in surgical settings, fitting the criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10 OR Table, Model 722033. The recall addresses a design defect in which the BIOS battery may deplete more rapidly than expected, causing the system to fail to start.
When the BIOS battery is fully depleted, the system's startup process is halted and the device will not boot. Critically, no warning messages are displayed to operators before or during battery depletion, leaving no advance notice of potential failure.
Two units are affected: one in the United States and one internationally. The devices were distributed worldwide.
Operators of affected devices should contact Philips Medical Systems Nederland B.V. for service and battery replacement. Facilities should verify device startup prior to clinical use.
The recalled product
- Product
- Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- bios-battery-depletion
- system-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 (3)
- Model Numbers: 722033
- UDI-DI: 00884838059078 Serial Numbers: 1
- 6
Distribution
Distributed nationwide across the United States.
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