BEUDAMED
    FDA Recall Completed

    CardioTek EP-TRACER Software V2.x.

    Recall: Z-1283-2022 · Initiated April 25, 2022

    Recall

    Recall Number
    Z-1283-2022
    Event Number
    90154
    Firm
    CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands
    FEI Number
    3008329188
    Product Code
    DQK
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    April 25, 2022

    Description

    CardioTek EP-TRACER Software V2.x.

    Reason

    Device did not pass electrical safety testing for adequate insulation.

    Action

    The firm issued a recall notification to consignees on 04/25/2022 via email. On 05/24/2022 the firm sent an updated field safety notice. The consignee can continue to use the device. The firm will contact the customer to schedule an appointment for the rework. The consignee is to pass on the letter to those that need to be made aware of the notice.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.

    Quantity

    146 units