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Terminated

Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.

FDA Recall Z-0432-2011 · Posted 2010-11-22

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-08-07
Date Terminated2010-12-01
Product Quantity1 unit

Reason for Recall

The affected device may not deliver appropriate defibrillation therapy.

Firm Action

Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution: to one account in Arkansas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050004PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304Philips Medical Systems · 2005-02-25

Official Source

View FDA Recall →

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

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