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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical

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  Class 2 Device Recall Philips Medical see related information
Date Initiated by Firm September 02, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on April 20, 2005
Recall Number Z-1226-03
Recall Event ID 27134
510(K)Number K021453  
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Model M4735A HeartStart XL Defibrillator//Monitor
Code Information Units with software versions A.02.00 or greater
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Brenda Getchell
978-659-2134
Manufacturer Reason
for Recall		 Instructions For Use include addtional information on configuration for selecting Power on Lead
FDA Determined
Cause 2		 Other
Action Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.
Quantity in Commerce 16,736 units
Distribution NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK
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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