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U.S. Department of Health and Human Services

Class 2 Device Recall S5 Control Display Module

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  Class 2 Device Recall S5 Control Display Module see related information
Date Initiated by Firm February 16, 2012
Date Posting Updated March 05, 2012
Recall Status1 Terminated 3 on November 09, 2012
Recall Number Z-1151-2012
Recall Event ID 61208
510(K)Number K060053  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA

The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Code Information Item number: 28-95-10; Serial numbers 28E53393 to 28E56334.
Recalling Firm/
Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
Manufacturer Reason
for Recall
Touch screen may be unresponsive, inhibiting user input.
FDA Determined
Cause 2
Mixed-up of materials/components
Action All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.
Quantity in Commerce 106 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong Kong, Indonesia, Iraq, Iran, Israel, Italy, Japan, Jordan, Canada, British Columbia, South Korea, Kuwait, La Reunion, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Morocco, Mexico, Monaco, New Zealand, Netherlands, Norway, Oman, Austria, Phillippines, Poland, Portugal, Puerto Rico, Qatar, Serbia, Russia, Saudi Arabia, Sweden, Switzerland, Singapore, Spain, South Africa, Syria, Thailand, Czechoslavakia, Tunisia, Turkey, Hungary, Vietnam, and the United Arab Ermirates
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