Medical device recalls Moderate risk

Schiller, Ag recalls CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

Recall date
July 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2734-2024
FDA classification
Class II
Brand / firm
Schiller, Ag
Sold / distributed
Worldwide - US distribution in the state of Florida and the countries of Austria, Belgium, Switzerland, Cyprus, Czechia, Germany, Spain, Finland, France, Great Britain, Ireland, Iceland, Italy, Luxembourg, Malta, The Netherlands, Norway, Portugal, Romania, Sweden, Slovenia, Australia, The United Ar…

Why it was recalled

Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

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

What was recalled

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

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