The Recall Desk
HighFDA (Devices)·Z-2289-2026·Announced 2026-06-10

[pending] Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3

Pending LLM rewrite. Source: FDA_DEVICE Z-2289-2026.

What this means for you

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: Pending LLM scoring against the rubric.

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 7B20/15, Model Numbers: 722068, 722226 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)00884838085367(21)547
  • (01)00884838099272(21)120
  • (01)00884838099272(21)122
  • (01)00884838099272(21)123
  • (01)00884838099272(21)124
  • (01)00884838099272(21)125
  • (01)00884838099272(21)126
  • (01)00884838099272(21)127
  • (01)00884838099272(21)153
  • (01)00884838099272(21)67
  • (01)00884838099272(21)209
  • (01)00884838099272(21)271
  • (01)00884838099272(21)675
  • (01)00884838099272(21)112
  • (01)00884838085367(21)467
  • (01)00884838085367(21)335
  • (01)00884838099272(21)113
  • (01)00884838099272(21)121
  • (01)00884838099272(21)139
  • (01)00884838099272(21)158

Distribution

Distributed nationwide across the United States.

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