Recall Z-1810-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
| Date | Jun 21, 2010 (initiated Dec 18, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 S |
| Quantity | 332 units |
| Distribution | Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031987 | POWERHEART AED G3, MODEL 9300 Cardiac Science, Jul 30, 2003 |