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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 12

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 Class 2 Device Recall LIFEPAK 12see related information
Date Initiated by FirmJanuary 27, 2003
Date PostedFebruary 05, 2003
Recall Status1 Terminated 3 on February 24, 2004
Recall NumberZ-0542-03
Recall Event ID 25289
510(K)NumberK002445 K010918 K973486 K990338 K991910 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
ProductLIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. Product is labeled with ''Medtronic Physio-Control, Redmond, WA''
Code Information Each unit is given a unique serial number. All LIFEPAK 12 units are affected.
Recalling Firm/
Manufacturer		 Medtronic Physio Control Corp
11811 Willows Rd NE
Redmond WA 98073
Manufacturer Reason
for Recall		Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
FDA Determined
Cause 2		Other
ActionConsignees were notified of recall action by letter dated January 2003. Letter advised consignees to follow recommendations for periodic inspections and to test device to verify readiness. A few weeks later the consignees were sent a correction letter along with user installable shields.
Quantity in Commercedomestic: 30,575 foreign: 15,467
DistributionWorldwide distribution, including government/military accounts.
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
510(K)s with Product Code = MKJ
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