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

Philips Azurion System with software versions: R2.2.O, R2.2.1… — recall Z-1647-2023

U.S. FDA — Device Enforcement · Netherlands · 2023-03-21 · Class II

As described by U.S. FDA — Device Enforcement: Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 72

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1647-2023
Date of alert
2023-03-21
Country / jurisdiction
Netherlands
Risk level
Class II
Notice type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece
Barcode (EAN/GTIN)
00884838085275
Reported risk: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.