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

Azurion 7 M20. X-ray Image guided Therapy System. — recall Z-2284-2023

U.S. FDA — Device Enforcement · Netherlands · 2023-06-12 · Class II

As described by U.S. FDA — Device Enforcement: Azurion 7 M20. X-ray Image guided Therapy System.

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-2284-2023
Date of alert
2023-06-12
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
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysi
Barcode (EAN/GTIN)
00884838085268
Reported risk: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
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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