Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0295-2027·Announced 2026-11-04

Philips Azurion 5 M20 Recalled for Unspecified Solid-State Drives

Philips is recalling 465 Azurion 5 M20 systems 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 because the unspecified solid-state drives may cause temporary or medically reversible adverse health consequences, such as loss of imaging functionality or inability to access images. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 465 units of the Philips Azurion 5 M20, model numbers 722228 and 722281. 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 potential hazards associated with these drives include 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. Consumers and healthcare facilities should contact Philips Medical Systems for further instructions on how to address the affected units.

The recalled product

Product: Philips Azurion 5 M20. Model Numbers: 722228, 722281.
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Imaging System
Hazard: loss-of-function
data-loss
Affected units: 465

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: 722228. UDI Numbers: (01)00884838099234(21)49
(01)00884838099234(21)159
(01)00884838099234(21)180
(01)00884838099234(21)273
(01)00884838099234(21)132
(01)00884838099234(21)533
(01)00884838099234(21)47
(01)00884838099234(21)522
(01)00884838099234(21)32
(01)00884838099234(21)23
(01)00884838099234(21)25
(01)00884838099234(21)62
(01)00884838099234(21)48
(01)00884838099234(21)153
(01)00884838099234(21)431
(01)00884838099234(21)113
(01)00884838099234(21)529
(01)00884838099234(21)659
(01)00884838099234(21)145
(01)00884838099234(21)567

Distribution

Distributed nationwide across the United States.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · loss of function