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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 Firm August 07, 2008
Date Posted November 22, 2010
Recall Status1 Terminated 3 on December 01, 2010
Recall Number Z-0432-2011
Recall Event ID 49384
510(K)Number K050004  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips 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
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.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution: to one account in Arkansas.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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