Allura Xper FD20/10 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 87 Allura Xper FD20/10 interventional X-ray 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 FD20/10 interventional X-ray systems, model number 722029, 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 87 units, of which 21 are in the United States and 66 outside it, carrying UDI-DI 00884838054219. 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 FD20/10; Model Numbers: 722029; 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: 722029
- UDI-DI: 00884838054219
- Serial Numbers: 71
- 91
- 7
- 94
- 62
- 88
- 36
- 97
- 21
- 100
- 30
- 63
- 60
- 129
- 95
- 126
- 110
- 56
Distribution
Distributed nationwide across the United States.
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