Philips Azurion 5 M12 Recalled for Unspecified Solid-State Drives
Philips is recalling 60 Azurion 5 M12 units because unspecified solid-state drives may cause loss of imaging functionality, blank displays, or inability to store or access images.
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 the source describes a risk of reduced reliability leading to loss of imaging functionality or data access, but it does not report any illnesses, injuries, or deaths.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 60 units of the Philips Azurion 5 M12 (Model Number: 722227) medical device. The recall is due to the potential installation of solid-state drives (SSDs) that are not specified in the Medical Device File. These unspecified SSDs may have different performance characteristics, including reduced reliability over time.
The source states that these performance issues may result in the loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images. The affected units were distributed worldwide, including in the United States and numerous other countries.
The source does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Philips Azurion 5 M12. Model Number: 722227.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 60
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 Number: 722227. UDI Numbers: (01)00884838099227(21)135
- (01)00884838099227(21)88
- (01)00884838099227(21)271
- (01)00884838099227(21)127
- (01)00884838099227(21)128
- (01)00884838099227(21)179
- (01)00884838099227(21)270
- (01)00884838099227(21)246
- (01)00884838099227(21)338
- (01)00884838099227(21)108
- (01)00884838099227(21)305
- (01)00884838099227(21)356
- (01)00884838099227(21)346
- (01)00884838099227(21)313
- (01)00884838099227(21)104
- (01)00884838099227(21)109
- (01)00884838099227(21)337
- (01)00884838099227(21)306
- (01)00884838099227(21)215
- (01)00884838099227(21)213
Distribution
Distributed nationwide across the United States.
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