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U.S. Department of Health and Human Services

Class 2 Device Recall Sorin S5 Perfusionn System

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 Class 2 Recall
Sorin S5 Perfusionn System
see related information
Date Posted November 04, 2013
Recall Status1 Terminated on July 10, 2014
Recall Number Z-0142-2014
Recall Event ID 66464
Premarket Notification
510(K) Number
K071318 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Code Information Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801
Recalling Firm/
Manufacturer
Sorin Group Deutschland GmbH
Lindberghstrasse 25
Munchen
For Additional Information Contact Cheri Voorhees
303-467-6527
Manufacturer Reason
for Recall
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Software Manufacturing/Software Deployment
Action Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers. The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site. Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice. For questions regarding this recall call 303-467-6527.
Quantity in Commerce 84
Distribution Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
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 = SORIN GROUP DEUTSCHLAND GMBH
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