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U.S. Department of Health and Human Services

Class 1 Device Recall LIFEPAK CR Plus Defibrillator/Monitor

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  Class 1 Device Recall LIFEPAK CR Plus Defibrillator/Monitor see related information
Date Initiated by Firm July 31, 2009
Date Posted September 14, 2009
Recall Status1 Terminated 3 on March 15, 2013
Recall Number Z-2030-2009
Recall Event ID 53035
510(K)Number K011144  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor.

Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.
Code Information Serial Numbers: 37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211, 37038365, 37135986, 37154526 and 37154638.
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact
425-867-4000
Manufacturer Reason
for Recall		 The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Physio-Control, Inc. notified Customers by phone beginning August 18, 2009. In addition, the recalling firm Issued an "Urgent Medical Device Recall" letter dated August 2009 informing Customers of the affected product and informing them that a Physio-Control representative will call and arrange for immediate device replacement. For further information, contact Physio-Control Customer Care at 1-800-442-1142.
Quantity in Commerce 34 devices (2 domestically & 32 internationally)
Distribution Worldwide Distribution -- US (DC and MN) and Japan.
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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