Imaging device may fail to start due to BIOS battery depletion
The Allura Xper CV20 device may fail to start if the BIOS battery depletes faster than expected. No warning message is shown before the battery becomes low or depleted.
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 is a Class II device with a functional defect that prevents normal operation and could impact patient care delivery. While no injuries or illnesses have been reported, the inability to start a medical device represents a risk-of-harm situation.
Plain-English summary
The Allura Xper CV20 (Model 722031), manufactured by Philips Medical Systems Nederland B.V., is being recalled because the BIOS battery may deplete faster than originally expected. When depleted, the system will not start, and users receive no warning before the battery is low or depleted.
The recalled devices have been distributed in the United States and numerous countries worldwide. At least 53 units outside the United States have been identified as affected by this issue.
The recalled product
- Product
- Allura Xper CV20; Model Numbers: 722031; 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: 722031
- UDI-DI: N/A
- Serial Numbers: 29
- 77
- 23
- 18
- 45
- 90
- 164
- 30
- 76
- 32
- 75
- 33
- 40
- 13
- 113
- 111
- 46
- 25
Distribution
Distributed nationwide across the United States.
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