Home / Recalls / Cardiac Science Corporation / Z-1938-2019

Z-1938-2019 Class II Terminated

Recalled by Cardiac Science Corporation — Deerfield, WI

Recall Details

Product Type: Devices
Report Date: July 10, 2019
Initiation Date: June 4, 2019
Termination Date: November 15, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5 devices

Product Description

Powerheart¿ G5 Automatic AED

Reason for Recall

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

Distribution Pattern

US distribution to Georgia, Texas, and Wisconsin.

Code Information

Model Number G5A 80A; AED Serial Number (UDI Number): D00000133922 )(01)00812394021222(11)190508(21)D00000133922), D00000133927 ((01)00812394021222(11)190509(21)D00000133927), D00000133930 ((01)00812394021222(11)190509(21)D00000133930), D00000133934 ((01)00812394021222(11)190509(21)D00000133934), D00000133936 )(01)00812394021222(11)190509(21)D00000133936).