Medical imaging device may fail to start due to battery depletion
Philips Allura Xper FD20 Biplane medical imaging devices may have BIOS batteries that deplete faster than expected, preventing startup without warning to operators.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm product—medical imaging equipment that may fail to operate—where no illnesses or injuries have been reported. The FDA Class II classification indicates potential for adverse health consequences from device failure that could delay critical diagnostic procedures.
Plain-English summary
Philips is recalling the Allura Xper FD20 Biplane, a medical imaging device used for fluoroscopic and interventional procedures. The affected devices have BIOS batteries that may deplete faster than anticipated during the design phase.
When the BIOS battery becomes depleted, the device cannot complete its startup process and will not start. Users receive no warning messages before the battery reaches low power or becomes fully depleted, leaving operators unaware of the issue until the system fails to boot.
A total of 501 units are affected by this recall, with 212 located in the United States and 289 overseas. The affected model numbers are 722008 and 722013. Healthcare facilities that have these devices should contact Philips Medical Systems Nederland B.V. for additional information and guidance.
The recalled product
- Product
- Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-depletion
- system-failure
- no-warning
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) 722008
- (2) 722013
- UDI-DI: (1) N/A
- (2) 00884838059061
- Serial Numbers: (1) 491
- 489
- 360
- 325
- 142
- 125
- 312
- 319
- 82
- 192
- 244
- 453
- 306
- 116
- 124
- 18270
Distribution
Distributed nationwide across the United States.
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