The Recall Desk
Severity pendingFDA (Devices)·Z-1346-2026·Announced 2026-02-18

Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - A

Pending LLM rewrite. Source: FDA_DEVICE Z-1346-2026.

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

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

The recalled product

Product
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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 (7)

  • System Model Numbers:(1)722067
  • (2)722225
  • (3)722235
  • UDI-DIs:(1)884838085350
  • (2)884838099265
  • (3)884838116788
  • Serial Numbers: All

Distribution

Distributed nationwide across the United States.