The Recall Desk
Severity pendingFDA (Devices)·Z-2285-2026·Announced 2026-06-10

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R

Pending LLM rewrite. Source: FDA_DEVICE Z-2285-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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 — Devices

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.

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