BEUDAMED
    FDA Recall Terminated

    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures

    Recall: Z-0160-2020 · Initiated July 23, 2019

    Recall

    Recall Number
    Z-0160-2020
    Event Number
    83508
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 23, 2019
    Terminated
    May 6, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures

    Reason

    An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases

    Action

    Siemens issued the customer notification on 7/23/19 via XP018/19/S. The Advisory Notice provides the problem, health risk and action to take: provided steps to the operator on how to easily release patient and proceed with exam. Siemens is developing a corrective action to resolve the issue, which will be released via Update Instruction XP021/19/S.

    Distribution

    Nationwide

    Quantity

    139 WW (33 US)