Philips Azurion and Allura imaging systems may shut down during power loss
Philips Azurion and Allura medical imaging systems configured with certain 1-Phase power supplies may shut down or fail to start if power is lost. The recall affects approximately 1,861 units distributed worldwide.
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 an FDA Class II medical device recall for a risk-of-harm product (medical imaging equipment). No injuries or illnesses have been reported in the source. The hazard is a potential shutdown or failure to start upon power loss, which per the rubric constitutes a High severity rating.
Plain-English summary
Philips Azurion and Allura medical imaging systems configured with a 1-Phase Uninterruptible Power Supply (UPS) are subject to this recall. The affected systems include 15 models with model numbers ranging from 722063 to 722282, distributed worldwide including in the United States.
The systems have the potential to shut down or fail to start if power to the equipment is lost. This could interrupt diagnostic imaging procedures and patient care.
Approximately 1,861 units are affected by this recall. The FDA classified this as a Class II recall. Users of affected Azurion and Allura systems should contact Philips Medical Systems Nederland B.V. for guidance on remediation or replacement of the 1-Phase UPS component.
The recalled product
- Product
- Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- system-shutdown
- power-loss
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)
- 1. Model Number/System Code (UDI)
- Serial Numbers: 722063 (00884838085275)
- 25
- 151
- 91
- 85
- 90
- 86
- 107
- 89
- 88
- 87
- 120
- 153
- 96
- 108. 2. Model Number/System Code (UDI)
- Serial Numbers: 722064 (00884838085282)
- 64
- 260
- 261
Distribution
Distributed nationwide across the United States.
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