Z-0166-2013Class II

SCP Pump Control Panel

Name: Z-0166-2013 SCP Pump Control Panel
Creator: Sorin Group USA, Inc.
Published: 2012-09-20
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2012-09-20 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed... on 2012-09-20. FDA classified it as Class II and gives the reason as "Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0166-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2012-10-29
Terminated: 2013-01-28
Recalling firm: LivaNova USA, Inc.
Product: SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Product code: DWA Control, Pump Speed, Cardiopulmonary Bypass
Reason for recall: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.
FDA root cause: Mixed-up of materials/components
Action: The firm, Sorin Group USA, Inc., sent an "URGENT FIELD SAFETY NOTICE" dated September 20, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. Customers were instructed to discontinue use of and segregate affected product for return and replacement to the firm; to complete and return the attached Customer Response Form via fax to: 303-467-6502 or email to: [email protected]; and if they have transferred the affected products to a third party, to pass this information to the Sorin Group. Further questions may be directed to Sorin Group Customer Service at 1-800-650-2623.
Quantity in commerce: 12 units (3 units USA and 9 units OUS)
Distribution: Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.
Product codes and lots: Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0166-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0166-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-29
Z-0167-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-29

Product code DWA

K011838Class IICentrifugal PumpStockert Instrumente GmbH / cleared 2002-02-05

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)