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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart XL

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 Class 2 Device Recall HeartStart XL see related information
Date Posted October 25, 2007
Recall Status1 Open
Recall Number Z-0062-2008
Recall Event ID 44751
510(K)Number K021453 
Product Classification defibrillator control board - Product Code MKJ
Product HeartStart XL Defibrillator/Monitor, Model: M4735A
Code Information S/N's:
Lot numbers(s) or serial number(s)
US00453446
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Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
978-687-1501
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall
Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.
FDA Determined
Cause 2
Package design/selection
Action Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction.
Quantity in Commerce 147 boards
Distribution Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Ireland, UK, France, Kuwait, Poland, and Germany
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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