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Class 2 Device Recall Medtronic Performer CPB |
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Date Initiated by Firm |
June 04, 2007 |
Date Posted |
July 23, 2007 |
Recall Status1 |
Terminated 3 on March 02, 2008 |
Recall Number |
Z-1090-2007 |
Recall Event ID |
38154 |
510(K)Number |
K052555 K070213
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Product Classification |
Electromechanical extracorporeal support device - Product Code DTQ
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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 MN 55428-1088
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For Additional Information Contact |
612-391-9000
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Manufacturer Reason for Recall |
Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = DTQ and Original Applicant = RAND S.R.L.
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