FDA recall Z-1938-2019
Cardiac Science Corporation · Class II · device
Product
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
US distribution to Georgia, Texas, and Wisconsin.
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-04
- Report date
- 2019-07-10
- Termination date
- 2021-11-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1938-2019