BEUDAMED
    FDA Recall Terminated

    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

    Recall: Z-1449-2015 · Initiated March 18, 2015

    Recall

    Recall Number
    Z-1449-2015
    Event Number
    70847
    Firm
    Hansen Medical Inc
    FEI Number
    3006026430
    Product Code
    DXX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 18, 2015
    Posted
    April 15, 2015
    Terminated
    September 23, 2015
    Address
    800 E Middlefield Rd, Mountain View, CA, 94043-4030

    Description

    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

    Reason

    Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.

    Action

    Hansen Medical sent an Urgent Notice - Field Safety Notice dated March 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you review the information in pages 1 and 2 with Hansen Medical personnel and acknowledge your understanding by signing the Field Safety Notice Training Form on page 3. If you need any further information regarding this issue, please do not hesitate to contact me via telephone at 650-404-2784.

    Distribution

    Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.

    Quantity

    19 total installed systems