Recall Z-1938-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
Powerheart G5 Automatic AED
| Date | Jun 4, 2019 |
| Status | Terminated |
| Reason | Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications. |
| Root cause | Process control |
| Action | Cardiac Science Corporation notified customers of the recall on about 06/04/2019 via phone call and "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Customers were instructed to examine inventory, remove any affected devices, and contact Cardiac Science immediately to arrange for return of affected devices and replacement of new devices. Contact can be made by phone to 800.426.0337 option 1 or by email at techsupport@cardiacscience.com. Distributors were instructed to determine who received the affected devices, inform customers that a Cardiac Science representative will contact them and p |
| Quantity | 5 devices |
| Distribution | US distribution to Georgia, Texas, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.