BEUDAMED
    FDA Recall Terminated

    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    Recall: Z-0666-2016 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0666-2016
    Event Number
    72202
    Firm
    MWT Materials, Inc.
    FEI Number
    3004863903
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 6, 2014
    Terminated
    July 13, 2021
    Address
    90 Dayton Ave, Building 21 Ste 6E, Passaic, NJ, 07055-7014

    Description

    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    Reason

    When not used correctly, Accusorb MRI products may overheat and lead to patient injury.

    Action

    MWT issued a letter dated 10/4/2014 via email to all distributors for further distribution to consignees. Tghe letter identified the affected product, problem and actions to be taken. Questions can be direct to [email protected].

    Distribution

    US Nationwide Distribution in the states of NY and MA.

    Quantity

    6 units