SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 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.
Recall
- Recall Number
- Z-0965-2011
- Event Number
- 57609
- Firm
- Sorin Group USA, Inc.
- FEI Number
- 1718850
- Product Code
- DTQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 12, 2010
- Posted
- January 26, 2011
- Terminated
- July 13, 2012
- Address
- 14401 W 65th Way, Arvada, CO, 80004
Description
SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 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.
Touch screen may become unresponsive, inhibiting user input.
All 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.
Worldwide Distribution.
79 units