The Recall Desk
Severity pendingFDA (Devices)·Z-2290-2026·Announced 2026-06-10

Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R

Pending LLM rewrite. Source: FDA_DEVICE Z-2290-2026.

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 7M12, Model Numbers: 722078, 722223 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)00884838099241(21)85
  • (01)00884838099241(21)312
  • (01)00884838099241(21)332
  • (01)00884838099241(21)533
  • (01)00884838099241(21)479
  • (01)00884838099241(21)189
  • (01)00884838099241(21)47
  • (01)00884838085251(21)840
  • (01)00884838099241(21)352
  • (01)00884838099241(21)681
  • (01)00884838099241(21)391
  • (01)00884838099241(21)328
  • (01)00884838085251(21)870
  • (01)00884838099241(21)388
  • (01)00884838099241(21)581
  • (01)00884838099241(21)570
  • (01)00884838099241(21)77
  • (01)00884838099241(21)448
  • (01)00884838099241(21)571
  • (01)00884838099241(21)495

Distribution

Distributed nationwide across the United States.

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