Allura Xper FD10 OR Table systems recalled over BIOS battery depletion
Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
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: Scored 2 as a component failure whose stated effect is that the system will not start; the notice describes no in-use hazard or patient harm.
Plain-English summary
Allura Xper FD10 OR Table interventional X-ray systems, model number 722033, are being recalled because the BIOS battery may deplete faster than was anticipated during the design phase.
When the battery is depleted, the start-up process of the system is halted and the system will not start. No user messages are shown before the battery is low on power or depleted.
The recall covers two units, one in the United States and one outside it, carrying UDI-DI 00884838059078 and serial numbers 1 and 6. Distribution was worldwide. The FDA has classified the action as Class II.
Affected sites should follow Philips' instructions for battery replacement and plan for the possibility of a system failing to start.
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.
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.
Part of a larger recall action
This product is one of 15 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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