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Terminated

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.

FDA Recall Z-1810-2010 · Posted 2010-06-21

Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-12-18
Date Terminated2011-12-08
Product Quantity332 units

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.

Firm 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 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

Distribution Pattern

Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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