BEUDAMED
    FDA Recall Terminated

    MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.

    Recall: Z-1608-2008 · Initiated February 25, 2008

    Recall

    Recall Number
    Z-1608-2008
    Event Number
    46863
    Firm
    Civco Medical Instruments Inc
    FEI Number
    1937223
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 25, 2008
    Posted
    May 21, 2008
    Terminated
    July 2, 2008
    Address
    102 1st St S, Kalona, IA, 52247-9589

    Description

    MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.

    Reason

    Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.

    Action

    Consignees were notified by a Recall Notification letter on 2/25/08. The letter informed users that the recalling firm will replace the affected product. It also requested that users return a recall notification acknowledging notification of recall. Users were instructed to contact their sales representative to arrange servicing or for additional information at 1-800-842-8688.

    Distribution

    Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.

    Quantity

    160