PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I…

Recall date

July 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2534-2024

FDA classification

Class II

Brand / firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Czech…

Why it was recalled

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079