Medical Imaging System May Fail to Start Due to Battery Depletion
Philips Allura Xper FD20/20 fluoroscopy systems may experience premature BIOS battery depletion, preventing system startup without prior warning. 115 units distributed worldwide are affected.
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is device non-functionality due to battery depletion, a theoretical risk without documented patient harm. This qualifies as a voluntary precautionary recall.
Plain-English summary
The Philips Allura Xper FD20/20 (Model 722038) medical imaging system is being recalled because the BIOS battery may deplete faster than initially anticipated during the design phase.
When the BIOS battery becomes depleted, the system startup process halts and the device will not start. No user messages are displayed before the battery becomes low or depleted, so operators may not be aware of the problem until the system fails to power on.
A total of 115 units have been distributed worldwide, including 34 in the United States and 81 outside the US across multiple countries. The affected devices are Model 722038, identified by specific serial numbers.
Healthcare facilities using affected Allura Xper FD20/20 systems should contact Philips Medical Systems Nederland B.V. for instructions on battery evaluation and corrective action to restore normal device operation.
The recalled product
- Product
- Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-depletion
- device-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: 722038
- UDI-DI: 00884838054226
- Serial Numbers: 39
- 63
- 42
- 55
- 67
- 99
- 60
- 71
- 141
- 115
- 7
- 78
- 108
- 106
- 167
- 118
- 130
- 49
Distribution
Distributed nationwide across the United States.
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