Philips Allura Xper FD20 Fluoroscopy System BIOS Battery Depletion
Philips Allura Xper FD20 fluoroscopy systems may experience premature BIOS battery depletion, causing unexpected system startup failures. No warning messages alert users before battery depletion.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a system availability issue (BIOS battery depletion preventing system startup) rather than a direct patient safety risk. This qualifies as a moderate precautionary recall.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling select Allura Xper FD20 fluoroscopy systems (Model Numbers 722006, 722012, and 722028) due to a BIOS battery issue. The BIOS battery in these systems may deplete faster than anticipated during the design phase.
When the BIOS battery becomes depleted, the system startup process will be halted and the system will not start. The system provides no warning messages to users before the battery becomes low on power or depleted. This results in unexpected system unavailability.
Approximately 5,067 units of affected fluoroscopy systems have been distributed worldwide: 1,626 units in the United States and 3,441 units in countries outside the United States. The affected systems are distributed globally across multiple regions including North America, Europe, Asia, Africa, and other areas.
Customers with affected equipment should contact Philips Medical Systems Nederland B.V. for information regarding this recall and any necessary battery servicing or replacement procedures.
The recalled product
- Product
- Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-failure
- 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: (1) 722006
- (2) 722012
- (3) 722028
- UDI-DI: (1) N/A
- (2) 00884838059054
- (3) 00884838054202
- Serial Numbers: (1) 535
- 2522
- 1364
- 2268
- 172
- 415
- 2324
- 1637
- 2533
- 1881
- 2158
- 1774
- 468
- 1477
Distribution
Distributed nationwide across the United States.
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