Allura Xper FD20 OR Table systems recalled over BIOS battery depletion
Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
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 FD20 OR Table interventional X-ray systems, model numbers 722015, 722023 and 722035, 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 298 units, of which 72 are in the United States and 226 outside it. 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 without prior warning.
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
- startup-failure
- device-unavailability
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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