Z-0964-2011

S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin...

Name: Z-0964-2011 S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin...
Creator: Sorin Group USA, Inc.
Published: 2010-11-12
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2010-11-12 / Terminated / root cause: design

FDA source

Sorin Group USA, Inc. began a recall of S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004... on 2010-11-12. The reason FDA records is "Touch screen may become unresponsive, inhibiting user input". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0964-2011
Status: Terminated
Initiated: 2010-11-12
Posted: 2011-01-26
Terminated: 2012-07-13
Recalling firm: LivaNova USA, Inc.
Product: S5 C5-System, Part No.: 58-00-00, 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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Touch screen may become unresponsive, inhibiting user input.
Root cause tag: design
FDA 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 any questions.
Quantity in commerce: 11 units
Distribution: Worldwide Distribution.
Product codes and lots: Serial Numbers: 58E00009 to 58E00026

Product code DTQ

K060053Class IIStockert S5 SystemSorin Group Deutschland GmbH / cleared 2006-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)