Agency classClass IIOur severity:High FDA (Devices)·Z-0298-2027·Announced 2026-11-04

Philips Azurion 7 M12 Recalled for Unspecified Solid-State Drives

Philips is recalling 602 Azurion 7 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a Class II medical device where unspecified solid-state drives may cause loss of imaging functionality or inability to store images. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 602 units of the Philips Azurion 7 M12 (Model Numbers 722078 and 722223). 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 affected systems may experience 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 source text does not report any illnesses, injuries, or deaths associated with this recall.

The affected units were distributed worldwide, including the United States and numerous international locations. Healthcare facilities should contact Philips Medical Systems Nederland B.V. for instructions on how to address the issue with the solid-state drives.

The recalled product

Product: Philips Azurion 7 M12. Model Numbers: 722078, 722223.
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Imaging System
Hazard: device-malfunction
data-loss
Affected units: 602

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: 722078. UDI Numbers: (01)00884838085251(21)302
(01)00884838085251(21)585
(01)00884838085251(21)293
(01)00884838085251(21)613
(01)00884838085251(21)546
(01)00884838085251(21)479
(01)00884838085251(21)278
(01)00884838085251(21)456
(01)00884838085251(21)571
(01)00884838085251(21)921
(01)00884838085251(21)165
(01)00884838085251(21)656
(01)00884838085251(21)657
(01)00884838085251(21)576
(01)00884838085251(21)121
(01)00884838085251(21)383
(01)00884838085251(21)239
(01)00884838085251(21)645
(01)00884838085251(21)379
(01)00884838085251(21)399

Distribution

Distributed nationwide across the United States.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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