Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Ma
FDA device recall Z-0623-06 · posted 2006-03-02 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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 Si
- Date initiated
- 2006-01-27
- Date posted
- 2006-03-02
- Date terminated
- 2006-06-25
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWERHEART AED G3A (K040438) | Cardiac Science, Inc. | 2004-07-01 |