Z-1938-2019 Class II Terminated
FDA device recall Z-1938-2019 was initiated by Cardiac Science Corporation on June 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 November 15, 2021). Affected quantity: 5 devices.
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).