Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1350-2026 — Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

U.S. FDA — Device Enforcement · Netherlands · 2026-01-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1350-2026
Date of alert
2026-01-26
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
884838099227
Reported risk: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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