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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Performer CPB

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 Class 2 Recall
Medtronic Performer CPB
see related information
Date Posted July 23, 2007
Recall Status1 Terminated on March 02, 2008
Recall Number Z-1090-2007
Recall Event ID 38154
Premarket Notification
510(K) Numbers
K052555  K070213 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
Code Information Model Number: R5100052-Serial Numbers: 115, 118, 124, 138, 140, 141, 148, 113, 116, 117, 122,127, 130, 137 103, 109, 132, 135, 105, 107, 108, 110, 131, 133.
Recalling Firm/
Manufacturer
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park, Minnesota 55428-1088
Manufacturer Reason
for Recall
Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
FDA Determined
Cause 2
DESIGN: Device Design
Action There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update.
Quantity in Commerce 24 units
Distribution Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France.
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 = DTQ and Original Applicant = RAND S.R.L.
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