Medical device recalls Moderate risk

Abbott Laboratories Inc. (St Jude Medical) recalls NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Recall date
April 22, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1549-2021
FDA classification
Class II
Brand / firm
Abbott Laboratories Inc. (St Jude Medical)
Sold / distributed
US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN

Why it was recalled

Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.

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

What was recalled

NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

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