The Recall Desk
Severity pendingFDA (Devices)·Z-2284-2026·Announced 2026-06-10

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2

Pending LLM rewrite. Source: FDA_DEVICE Z-2284-2026.

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 3M12, Model Numbers: 722063, 722221 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 (16)

  • UDI (01)00884838099203(21)3
  • (01)00884838099203(21)7
  • (01)00884838085275(21)131
  • (01)00884838099203(21)54
  • (01)00884838085275(21)84
  • (01)00884838099203(21)6
  • (01)00884838099203(21)93
  • (01)00884838085275(21)132
  • (01)00884838099203(21)69
  • (01)00884838099203(21)9
  • (01)00884838099203(21)115
  • (01)00884838099203(21)85
  • (01)00884838099203(21)19
  • (01)00884838099203(21)49
  • (01)00884838099203(21)108
  • (01)00884838085275(21)108.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category