Recall Z-0958-2011 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sorin Group USA, Inc.
S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
| Date | Jan 26, 2011 (initiated Nov 12, 2010) |
| Status | Terminated |
| Reason | Touch screen may become unresponsive, inhibiting user input. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 3389 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060053 | STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Jun 2, 2006 |