BEUDAMED
    FDA Recall Terminated

    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    Recall: Z-1327-2013 · Initiated April 25, 2013

    Recall

    Recall Number
    Z-1327-2013
    Event Number
    65028
    Firm
    Hologic, Inc.
    FEI Number
    1221300
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 25, 2013
    Posted
    May 17, 2013
    Terminated
    August 21, 2014
    Address
    35 Crosby Dr, Bedford, MA, 01730-1450

    Description

    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    Reason

    The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

    Action

    The firm, Hologic, Inc. sent an "Urgent: Medical Device Recall" letter dated April 25, 2013, via FedEx to consignees/customers notifying them of the software defect and providing them with corrected user installable software version. The customers were instructed to complete and return the Enclosure to Customer Notification, Confirmation of Notification form via fax to Hologic at 866-652-8674 or mail the document to Hologic using the enclosed pre-addressed, pre-paid return envelope. Should you have any questions regarding this recall, require further information or assistance with the software installation call Hologic's Help Desk at 1-800-321-4659.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.

    Quantity

    2780