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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

Recommended Action

Per FDA guidance

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.