Recall Z-1938-2019— Cardiac Science Corporation
Class II · Terminated
Class II FDA medical device recall by Cardiac Science Corporation, initiated 2019-06-04, terminated 2021-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Powerheart¿ G5 Automatic AED. Reason: Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications..
- Recalling firm
- Cardiac Science Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-04
- Terminated
- 2021-11-15
- Firm location
- Deerfield, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.