Medical device recalls Moderate risk

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 70, Model Number: 718133

Recall date
October 7, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0353-2025
FDA classification
Class II
Brand / firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Isl…

Why it was recalled

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

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 Zenition 70, Model Number: 718133

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