Medical imaging device may fail to start due to rapid battery depletion
Philips Allura Xper FD20/10 fluoroscopy systems may fail to start if the BIOS battery depletes faster than designed. No warning is given before failure occurs.
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: Class II medical device with no reported injuries or illnesses. The hazard is device malfunction rather than direct patient harm. This is a proactive design correction for a battery depletion issue.
Plain-English summary
Philips Medical Systems is recalling the Allura Xper FD20/10 fluoroscopy imaging system (Model 722029) due to a BIOS battery issue. Approximately 87 units have been distributed worldwide, including 21 in the United States, with the remainder distributed internationally.
The BIOS battery may deplete faster than anticipated during the design phase. When the battery is depleted, the system will not start. The system provides no notification to users before the battery becomes depleted.
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
- device-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 (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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