Medical device recalls Moderate risk

Cardiac Science Corporation recalls Powerheart¿ G5 Automatic AED

Recall date
June 4, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1938-2019
FDA classification
Class II
Brand / firm
Cardiac Science Corporation
Sold / distributed
US distribution to Georgia, Texas, and Wisconsin.

Why it was recalled

Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.

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

What was recalled

Powerheart¿ G5 Automatic AED

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