Reported Feb 18, 2026 · Ongoing

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X,…

Philips Medical Systems Nederland B.v.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A

Is this the product you have?

  • Azurion 3 M12 System Model Numbers
    • (1) 722063
    • (2) 722221
    • (3) 722229
  • Software Version Number - All versions
    • R1.X
    • R2.X
    • R3.X
Lot codes and dates
  • System Model Numbers
    • (1) 722063
    • (2) 722221
    • (3) 722229
  • UDI-DIs
    • (1) 884838085275
    • (2) 884838099203
    • (3) 884838116726
  • Serial NumbersAll
Amount recalled
291 units (27 US, 264 OUS)

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.