Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2285-2026·Announced 2026-06-10

Philips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue

Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.

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 device is subject to an FDA Class II recall involving a software malfunction that results in unusable clinical images, but no injuries or hospitalizations were reported in the source text.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 27 Philips Azurion 3M15 units (Model Numbers 722064 and 722222) running software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5, and R2.2.6 with the Roadmap Pro Software key.

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. This issue may occur after a user performs a pedal tap, which is defined as shortly touching the footswitch pedal without generating an X-ray image. This action may cause a dark image during the subsequent fluoroscopy run.

This recall is distributed nationwide in the US.

The recalled product

Product: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Imaging Systems
Hazard: malfunction
unusable-images
Affected units: 27

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)

UDI (01)00884838085282(21)209
(01)00884838099210(21)100
(01)00884838099210(21)254
(01)00884838099210(21)256
(01)00884838099210(21)257
(01)00884838099210(21)265
(01)00884838099210(21)255
(01)00884838099210(21)99
(01)00884838085282(21)260
(01)00884838085282(21)261
(01)00884838099210(21)69
(01)00884838099210(21)12
(01)00884838085282(21)314
(01)00884838085282(21)259
(01)00884838099210(21)15
(01)00884838099210(21)19
(01)00884838099210(21)23
(01)00884838099210(21)17
(01)00884838085282(21)258
(01)00884838099210(21)55

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · malfunction