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U.S. Department of Health and Human Services

Class 2 Device Recall Stockert S5 System I Sorin C5 System

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  Class 2 Device Recall Stockert S5 System I Sorin C5 System see related information
Date Initiated by Firm December 04, 2013
Date Posted January 28, 2014
Recall Status1 Terminated 3 on December 28, 2015
Recall Number Z-0856-2014
Recall Event ID 67199
510(K)Number K071318  K093882  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product S5/C5 Heart-lung machine

Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Code Information S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00
Recalling Firm/
Manufacturer		 Sorin Group Deutschland GmbH
Lindberghstrasse 25
Munchen Germany
For Additional Information Contact Amritt Khorran
303-467-6306
Manufacturer Reason
for Recall		 Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
FDA Determined
Cause 2		 Device Design
Action Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.
Quantity in Commerce 323
Distribution Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.
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 = DTQ and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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