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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 20

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  Class 2 Device Recall LIFEPAK 20 see related information
Date Initiated by Firm January 08, 2008
Date Posted March 29, 2008
Recall Status1 Terminated 3 on September 04, 2013
Recall Number Z-1050-2008
Recall Event ID 46351
510(K)Number K012274  
Product Classification External Automatic Defibrillator - Product Code MKJ
Product Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052
Code Information Serial Numbers (domestic units): 36133753, 36133760, 36139018, 36139023, 36139030, 36137448, 36138998, 36141356, 36141357, 36141358, 36141360, 36141361, 36141362, 36141363, 36141365, 36141366, 36141367, 36141370, 36141373, 36141378, 36141380, 36141381, 36141382, 36141383, 36141384, 36141393, 36141394, 36141395, 36141396, 36141399, 36141400, 36142717, 36142718, 36142730, 36142731, 36141386, 36141398, 36133739, 36133740, 36133742, 36133743, 36133744, 36133745, 36133746, 36133747, 36133748, 36133749, 36133750, 36133751, 36133752, 36133754, 36133755, 36133756, 36133757, 36133758, 36133759, 36137218, 36137219, 36137220, 36137222, 36137224, 36137225, 36137226, 36137227, 36137230, 36137231, 36137352, 36137353, 36137355, 36137356, 36137357, 36137359, 36137360, 36137361, 36137362, 36137363, 36137364, 36137365, 36137366, 36137367, 36137368, 36137369, 36139002, 36139010  Serial Numbers (international units): 36137354, 36137358, 36137370, 36137371, 36137372, 36138999, 36139000, 36139005, 36139006, 36139007, 36139009, 36139011, 36139012, 36139013, 36139014, 36139021, 36139024, 36139025, 36139031 
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact Todd Bandy
425-867-4000 Ext. 4644
Manufacturer Reason
for Recall		 Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units.
Quantity in Commerce 103 total devices - 84 domestic, 19 international
Distribution Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany.
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 = MEDTRONIC PHYSIO-CONTROL CORP.
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