—#96785

Product

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 product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K060053
Affected lot / code info: Serial Numbers: 28E50183 to 28E55913

Why it was recalled

Touch screen may become unresponsive, inhibiting user input.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2010-11-12
Posted by FDA: 2011-01-26
Terminated: 2012-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.