Agency classClass IIOur severity:High FDA (Devices)·Z-2288-2026·Announced 2026-06-10

Philips Azurion 7B12 Roadmap Pro may produce unusable dark images

Philips Azurion 7B12/12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

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: FDA Class II recall where imaging may be unusable during a procedure, a risk of harm with no injuries reported in the source.

Plain-English summary

Philips Azurion 7B12/12 systems, model numbers 722067 and 722225, with software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 and the Roadmap Pro software key, are being recalled. The action covers 51 units.

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap, briefly touching the footswitch pedal without generating an X-ray image; the pedal tap may cause a dark image with the next fluoroscopy run. The FDA classified the action as Class II.

Distribution was nationwide in the United States. The systems are installed in hospital interventional suites rather than sold to consumers.

Facilities should identify affected systems using the model numbers and UDI codes in the recall notice and follow the instructions issued by Philips.

The recalled product

Product: Philips Azurion 7B12/12, Model Numbers: 722067, 722225 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 — Interventional X-ray system
Hazard: imaging-loss
software-issue
roadmap-pro
class-ii
Affected units: 51

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)00884838099265(21)104
(01)00884838085350(21)221
(01)00884838099265(21)153
(01)00884838099265(21)46
(01)00884838099265(21)28
(01)00884838085350(21)250
(01)00884838099265(21)72
(01)00884838099265(21)208
(01)00884838099265(21)41
(01)00884838099265(21)122
(01)00884838099265(21)147
(01)00884838085350(21)225
(01)00884838099265(21)262
(01)00884838099265(21)112
(01)00884838099265(21)110
(01)00884838099265(21)207
(01)00884838099265(21)68
(01)00884838099265(21)177
(01)00884838099265(21)29
(01)00884838099265(21)71

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 · imaging loss