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U.S. Department of Health and Human Services

Class 2 Device Recall S5 C5System

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 Class 2 Device Recall S5 C5Systemsee related information
Date Initiated by FirmNovember 12, 2010
Date PostedJanuary 26, 2011
Recall Status1 Terminated 3 on July 13, 2012
Recall NumberZ-0964-2011
Recall Event ID 57609
510(K)NumberK060053 
Product Classification Cardiopulmonary Bypass Heart-Lung Machine Console - Product Code DTQ
ProductS5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Code Information Serial Numbers: 58E00009 to 58E00026
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
303-467-6306
Manufacturer Reason
for Recall		Touch screen may become unresponsive, inhibiting user input.
FDA Determined
Cause 2		Device Design
ActionAll affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.
Quantity in Commerce11 units
DistributionWorldwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTQ
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