Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user
FDA device recall Z-1810-2010 · posted 2010-06-21 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- Reason for recall
- The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.
- Action taken
- Customer notification letters were mailed to US end users and distributors (final consignees) between December 18 and 23, 2009 by USPS certified mail, return receipt requested. Notification letters were sent by FedEx to Canadian distributors (final consignees) on December 23, 2009. Secondary consignee (distributor) letters were mailed on December 23, 2009. Letters advise user to check the status indicator on front of AED to determine if it is rescue ready. Users are advised to keep the AED in service and to perform the Daily and Monthly Scheduled Maintenance as outlined in the Operator and Service Manual. Questions about this communication should be addressed to 1.877.901.1788 toll free from inside the US, or to email .
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 332 units
- Distribution
- Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.
- Date initiated
- 2009-12-18
- Date posted
- 2010-06-21
- Date terminated
- 2011-12-08
- 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 G3, MODEL 9300 (K031987) | Cardiac Science | 2003-07-30 |