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U.S. Department of Health and Human Services

Class 3 Device Recall Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.

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 Class 3 Device Recall Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.see related information
Date Initiated by FirmAugust 07, 2008
Date PostedNovember 22, 2010
Recall Status1 Terminated 3 on December 01, 2010
Recall NumberZ-0432-2011
Recall Event ID 49384
510(K)NumberK050004 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductPhilips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
Code Information Serial Number: B08G-01884
Recalling Firm/
Manufacturer		 Philips Medical Systems
2301 5th Ave Ste 200
Seattle WA 98121
For Additional Information Contact
206-664-5290
Manufacturer Reason
for Recall		The affected device may not deliver appropriate defibrillation therapy.
FDA Determined
Cause 2		Employee error
ActionPhilips 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.
Quantity in Commerce1 unit
DistributionNationwide Distribution: to one account in Arkansas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MKJ
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