Z-1902-2008

Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system

Name: Z-1902-2008 Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system
Creator: Levitronix, Llc
Published: 2008-03-17
License: https://open.fda.gov/license/

Levitronix, LLC / initiated 2008-03-17 / Terminated / root cause: design

FDA source

Levitronix, Llc began a recall of Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system on 2008-03-17. The reason FDA records is "Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit". 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-1902-2008
Status: Terminated
Initiated: 2008-03-17
Posted: 2008-07-23
Terminated: 2010-07-06
Recalling firm: Levitronix, LLC
Product: Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit
Root cause tag: design
FDA root cause: Device Design
Action: Levitronix issued an Urgent - Voluntary Device Correction letter on 3/17/08 mailed to the US distributor and requested to contact their accounts. The letter revises the warning in the CentriMag Console Manual. Levitronix is issuing revised manuals. On March 13, 2008 the firm emailed and mailed (FedEx) to the one Canadian Hospital and Health Canada was informed of the Voluntary Advisory Notice via email on Wednesday, March 19, 2008. Rest of the World: Wednesday, March 12, 2008 through Monday, March 17, 2008. The Notice was issued as a Voluntary Advisory Notice after review and follow up with the UK MHRA. On 7/24/08 the firm issued a revised Recall Letter to advise users not to use Valley Lab Force FX-C or SSE2L Electrosurgery device with the firm's CentriMag Blood Pumping System and include the significant risk to health. The firm revised their letter and Black Box Warning and reissued the letters to the hospital, surgeons, etc. on 7/24/08. On 2/5/09 the firm issued a "Follow-Up to Urgent Device Correction of 3/17/08 " to advise users of the software upgrade to be installed in the CentrigMag Primary software Version 3.0 and CentriMag Back Up console , software version 2.0. Site visits will be made by Levitronix between Feb 2009 and April 2009 , software upgrade installed and new Operating Manuals provided.
Quantity in commerce: 237 units
Distribution: Worldwide Distribution: USA, Canada, Switzerland, UK, Italy, France, Greece, Spain, Slovenia, Czech, Turkey, South Africa, Argentina, Chile, Panama, Singapore, Taiwan, Israel, and Saudi Arabia.
Product codes and lots: All serial numbers

Product code KFM

K051209Class IILevitronix Centrimag Back-Up ConsoleLevitronix, LLC / cleared 2005-09-08

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)