Z-0856-2014Class II

S5/C5 Heart-lung machine

Name: Z-0856-2014 S5/C5 Heart-lung machine
Creator: Sorin Group Deutschland GmbH
Published: 2013-12-04
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2013-12-04 / Terminated / root cause: design

FDA source

Sorin Group Deutschland GmbH began a recall of S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6)... on 2013-12-04. FDA classified it as Class II and gives the reason as "Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response". 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-0856-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-04
Posted: 2014-01-28
Terminated: 2015-12-28
Recalling firm: LivaNova Deutschland GmbH
Product: S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
Root cause tag: design
FDA root cause: Device Design
Action: Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.
Quantity in commerce: 323
Distribution: Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.
Product codes and lots: S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0856-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0856-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0857-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code DTQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)