Z-2866-2016Class II

Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console

Name: Z-2866-2016 Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console
Creator: Sorin Group USA, Inc.
Published: 2016-08-25
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2016-08-25 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during... on 2016-08-25. FDA classified it as Class II and gives the reason as "Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2866-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Posted: 2016-09-21
Terminated: 2017-05-26
Recalling firm: LivaNova USA, Inc.
Product: Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Sorin Group Deutschland GmbH created Field Correction Order (FCO) 2016-003 on August 11, 2016 to replace the affected power supply with a new unit. The customers will be contacted by the Field Service Representatives to schedule the replacement at the customer facilities. No direct action is required by the customer.
Quantity in commerce: 5264 Units Worldwide
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.
Product codes and lots: Item No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670 Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679 Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664 Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2866-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2866-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)