Z-1158-2012

SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen...

Name: Z-1158-2012 SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen...
Creator: Sorin Group USA, Inc.
Published: 2012-02-16
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2012-02-16 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way... on 2012-02-16. The reason FDA records is "Touch screen may be unresponsive, inhibiting user input". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1158-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-03-05
Terminated: 2012-11-09
Recalling firm: LivaNova USA, Inc.
Product: SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is 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 be unresponsive, inhibiting user input.
FDA root cause: Mixed-up of materials/components
Action: All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.
Quantity in commerce: 2 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong Kong, Indonesia, Iraq, Iran, Israel, Italy, Japan, Jordan, Canada, British Columbia, South Korea, Kuwait, La Reunion, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Morocco, Mexico, Monaco, New Zealand, Netherlands, Norway, Oman, Austria, Phillippines, Poland, Portugal, Puerto Rico, Qatar, Serbia, Russia, Saudi Arabia, Sweden, Switzerland, Singapore, Spain, South Africa, Syria, Thailand, Czechoslavakia, Tunisia, Turkey, Hungary, Vietnam, and the United Arab Ermirates
Product codes and lots: Item number: 58-00-00 Serial numbers 58E00023 to 58E20030.

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)