Philips Allura Xper Medical Imaging Systems Battery Depletion Recall
Philips Allura Xper FD20/15 imaging systems are recalled because BIOS batteries may deplete faster than expected, preventing system startup. No warning messages appear before battery 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: This Class II device recall involves a battery malfunction that prevents system operation. No injuries, illnesses, or adverse events have been reported, and the hazard is operational failure rather than a direct patient safety risk with documented harm.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20/15 medical imaging system (Model 722058). Approximately 300 units are affected, including 69 units in the United States and 231 units distributed internationally.
The BIOS battery in affected units may deplete faster than was anticipated during the product's design phase. Once the battery becomes fully depleted, the system will not start and cannot be powered on. The system does not display warning messages to users when the battery level is low or before it becomes depleted.
Healthcare facilities using affected systems should contact the recalling manufacturer, Philips Medical Systems Nederland B.V., for instructions on how to proceed. No injuries or illnesses related to this issue have been reported.
The recalled product
- Product
- Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-depletion
- system-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: 722058
- UDI-DI: 00884838059115
- Serial Numbers: 337
- 178
- 249
- 22
- 202
- 279
- 254
- 285
- 71
- 186
- 82
- 85
- 162
- 138
- 24
- 365
- 203
- 167
Distribution
Distributed nationwide across the United States.
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