Philips Heartstart FRx automated external defibrillator (AED), Model 861304
FDA Recall Z-1193-2010 · Posted 2010-03-23
Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-11-02
Date Terminated2013-05-23
Product Quantity92 units distributed domestically, 452 units distributed internationally
Reason for Recall
Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
Firm Action
The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution.
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.