Z-2439-2020Class II

Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI...

Name: Z-2439-2020 Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI...
Creator: LivaNova Deutschland GmbH
Published: 2019-08-26
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2019-08-26 / Terminated / root cause: design

FDA source

LivaNova Deutschland GmbH began a recall of Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 on 2019-08-26. FDA classified it as Class II and gives the reason as "The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature...". 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-2439-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-26
Posted: 2020-07-08
Terminated: 2021-04-22
Recalling firm: LivaNova Deutschland GmbH
Product: Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
Product code: DWA Control, Pump Speed, Cardiopulmonary Bypass
Reason for recall: The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued an Urgent Field Safety Notice, SCP Control panel (Subset) dated August 29, 2019 via USPS on August 29, 2019 to inform consignees that LivaNova is executing a voluntary medical device correction a limited subset of SCP control panels (references 60-02-15 & 60-02-50) due to an observed trend in reported complaints. The letter describes immediate action to be taken by customers. It states: LivaNova is initiating the proactive replacement of potentially affected angle encoder lots in the field in order to reduce the likelihood of the occurrence of the above described issue. Actions to be taken by the Customer/User Pending the replacement of affected angle encoder(s) would be completed, LivaNova is kindly requesting SCP system users to take the following actions, without any delay: 1. Affected SCP control panel(s) listed in Attachment 1 should be quarantined. Your LivaNova representative may support you in this activity (refer to contact reference person at the end of this letter). 2. In case of urgent medical need, affected devices could be used, provided the SCP system operating instructions would be strictly followed, especially safety instructions related to the pump operation. Users should: a. ensure to have a SCP emergency drive unit ready for use, b. be familiar with the mounting as well as the functioning of the emergency drive unit. As reported in the operating instructions, hand cranking remains an option in case it would become necessary to operate the SCP manually. 3. Please complete and return the Customer Response Form (Attachment 2) by e-mail to [email protected]. For questions regarding this Field Safety Notice, please contact your LivaNova representative, or LivaNova Customer Quality organization at [email protected]. A copy of this letter has been provided to the U.S. Food and Drug Administration (FD
Quantity in commerce: 8
Distribution: US: FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA OUS: Canada - Uzbekistan - Turkey - Tunisia - Taiwan - South Africa - Serbia - Saudi Arabia - Russia - Poland - Mexico - Korea(Rep. of) - India - Hong Kong - Colombia - China - Brazil - Bahrain - Argentina - Algeria - Italy - Germany
Product codes and lots: Serial Number: 60S14735 60S14877 60S14715 60S14716 60S14736 60S14755 60S14707 60S14708

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2439-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2439-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2440-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

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)