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.
FDA Recall Z-0958-2011 · Posted 2011-01-26
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Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDTQ
Date Initiated2010-11-12
Date Terminated2012-07-13
Product Quantity3389 units
Reason for Recall
Touch screen may become unresponsive, inhibiting user input.
Firm 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 any questions.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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