Z-0142-2014Class II

S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended...

Name: Z-0142-2014 S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended...
Creator: Sorin Group Deutschland GmbH
Published: 2013-09-24
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2013-09-24 / Terminated / root cause: software

FDA source

Sorin Group Deutschland GmbH began a recall of S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for... on 2013-09-24. FDA classified it as Class II and gives the reason as "Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0142-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-24
Posted: 2013-11-04
Terminated: 2014-07-10
Recalling firm: LivaNova Deutschland GmbH
Product: S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 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 Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers. The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site. Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice. For questions regarding this recall call 303-467-6527.
Quantity in commerce: 84
Distribution: Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
Product codes and lots: Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0142-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0142-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code DTQ

K071318Class IIModification to: Stockert S5 SystemSorin Group Deutschland GmbH / cleared 2007-07-06

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)