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

Z-1938-2019 Class II Terminated

Recalled by Cardiac Science Corporation — Deerfield, WI

FDA device recall Z-1938-2019 was initiated by Cardiac Science Corporation on Jun 4, 2019 and is designated Class II. Reason for recall: Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications. The recall status is terminated (terminated Nov 15, 2021). Affected quantity: 5 devices.

Recall details

Product Type: Devices
Report Date: Jul 10, 2019
Initiation Date: Jun 4, 2019
Termination Date: Nov 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).

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1938-2019
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.