BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1902-2008 · Initiated March 17, 2008

    Recall

    Recall Number
    Z-1902-2008
    Event Number
    47409
    Firm
    Levitronix, Llc
    FEI Number
    3003395347
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 17, 2008
    Posted
    July 23, 2008
    Terminated
    July 6, 2010
    Address
    45 1st Ave, Waltham, MA, 02451-1105

    Description

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

    Reason

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

    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.

    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.

    Quantity

    237 units