Recall Z-0623-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
| Date | Mar 2, 2006 (initiated Jan 27, 2006) |
| Status | Terminated |
| Reason | Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge. |
| Root cause | Process control |
| Action | Affected consignees were notified via telephone. If no phone contact could be made, a Urgent: Medical Device Recall letter dated 02/02/06 was sent with return receipt requested. Customers were asked to locate affected devices and remove them from service. A new AED would be sent to the customers and the customers are asked to return the affected device. |
| Quantity | 91 |
| Distribution | 58 customers within the US: AZ, CA, CO, DC,FL, GA, Nationwide, Hungary and Singapore. IL, IN, KS, KY, LA, MI, MO, NC, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. 2 customers OUS to include: Hungary and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040438 | POWERHEART AED G3A Cardiac Science, Inc., Jul 1, 2004 |