The Recall Desk
Severity pendingFDA (Devices)·Z-2287-2026·Announced 2026-06-10

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an

Pending LLM rewrite. Source: FDA_DEVICE Z-2287-2026.

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 5M20, Model Numbers: 722228 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)00884838099234(21)67
  • (01)00884838099234(21)49
  • (01)00884838099234(21)10
  • (01)00884838099234(21)36
  • (01)00884838099234(21)64
  • (01)00884838099234(21)110
  • (01)00884838099234(21)328
  • (01)00884838099234(21)149
  • (01)00884838099234(21)213
  • (01)00884838099234(21)45
  • (01)00884838099234(21)159
  • (01)00884838099234(21)18
  • (01)00884838099234(21)231
  • (01)00884838099234(21)61
  • (01)00884838099234(21)204
  • (01)00884838099234(21)273
  • (01)00884838099234(21)76
  • (01)00884838099234(21)150
  • (01)00884838099234(21)132
  • (01)00884838099234(21)189

Distribution

Distributed nationwide across the United States.

Related recalls

Same category