Philips Azurion S Medical Device Recalled for SSD Reliability Issues
Philips is recalling Azurion S units because non-specified solid-state drives may cause loss of imaging functionality, blank displays, or data storage failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as Class II and involves a hardware reliability defect that may cause loss of imaging functionality or data access, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Philips Azurion S, Model Number 722285. The recall involves 1 unit distributed worldwide, including the United States and numerous international locations.
The recall is due to the potential installation of Solid-State Drives (SSDs) that are not specified in the Medical Device File. These non-specified SSDs may have different performance characteristics, including reduced reliability over time. This reduced reliability may result in the loss of imaging functionality or motorized movement, a blank or black display, and the inability to store newly acquired images or access previously acquired images.
The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with the recall, nor does it report any illnesses, injuries, or deaths associated with the device.
The recalled product
- Product
- Philips Azurion S. Model Number: 722285.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 1
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 (1)
- 1. Model Number: 722285. UDI Number: (01)00884838125681(21)7. Serial Number: 7.
Distribution
Distributed nationwide across the United States.
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