Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0292-2027·Announced 2026-11-04

Philips Azurion 3 M12 Recalled for Unspecified Solid-State Drive Reliability Issues

Philips is recalling 95 Azurion 3 M12 systems because unspecified solid-state drives may cause loss of imaging functionality, blank displays, or inability to store 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 involves a reliability defect in solid-state drives that may cause loss of imaging functionality or data access. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 95 units of the Philips Azurion 3 M12, model numbers 722063 and 722221. 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.

The identified hazards include 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 provide specific instructions for consumers or healthcare providers on how to address the recall, such as contacting a representative or stopping use of the device. The source does not report any illnesses, injuries, or deaths associated with this recall.

The recalled product

Product: Philips Azurion 3 M12. Model Numbers: 722063, 722221.
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Imaging Equipment
Hazard: reliability-defect
data-loss
Affected units: 95

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: 722063. UDI Numbers: (01)00884838085275(21)56
(01)00884838085275(21)96
(01)00884838085275(21)98
(01)00884838085275(21)77
(01)00884838085275(21)145
(01)00884838085275(21)47
(01)00884838085275(21)80
(01)00884838085275(21)146
(01)00884838085275(21)117
(01)00884838085275(21)99
(01)00884838085275(21)104
(01)00884838085275(21)3
(01)00884838085275(21)144
(01)00884838085275(21)62
(01)00884838085275(21)61
(01)00884838085275(21)22
(01)00884838085275(21)153
(01)00884838085275(21)40
(01)00884838085275(21)70
(01)00884838085275(21)30

Distribution

Distributed nationwide across the United States.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · reliability defect