Philips Azurion 3 M15 Medical Device Recall for Unspecified SSDs
Philips is recalling 519 Azurion 3 M15 units worldwide because unspecified solid-state drives may cause loss of imaging functionality, motorized movement, or data access.
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 does not report any illnesses, injuries, or deaths.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 519 units of the Philips Azurion 3 M15 (Model Numbers 722064, 722222, and 722280). 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. This 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 affected units were distributed worldwide, including in the United States and numerous other countries. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 519
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: 722064. UDI Numbers: (01)00884838085282(21)258
- (01)00884838085282(21)229
- (01)00884838085282(21)291
- (01)00884838085282(21)64
- (01)00884838085282(21)218
- (01)00884838085282(21)335
- (01)00884838085282(21)161
- (01)00884838085282(21)169
- (01)00884838085282(21)297
- (01)00884838085282(21)479
- (01)00884838085282(21)190
- (01)00884838085282(21)268
- (01)00884838085282(21)220
- (01)00884838085282(21)375
- (01)00884838085282(21)173
- (01)00884838085282(21)359
- (01)00884838085282(21)256
- (01)00884838085282(21)290
- (01)00884838085282(21)502
- (01)00884838085282(21)130
Distribution
Distributed nationwide across the United States.
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