BEUDAMED
    FDA Enforcement Class II Terminated

    MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.

    Recall: Z-2388-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2388-2020
    Event ID
    85719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2020
    Initiation Date
    May 7, 2020
    Classification Date
    June 16, 2020
    Termination Date
    September 29, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355, United States

    Description

    MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.

    Reason

    If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.

    Code Info

    Serial Numbers (distributed in the US): 1026 1057 1348 1426 1027 1274 1292 1360 1324 1728 1372 1744 1036 1038 1620 1235 1751 1423 1379 1425 1342 1740 1445 1650 1058 1409 1277 1025 1253 1225 1749 1747 1422 1275 1228 1449 1707 1767 1387 1391 1206 1217 1250 1082 1357 1354 1256 1031 1339 1034 1219 1437 1289 1359 1045 1429 1408 1717 1051 ***Updated 8/18/2020*** 1775 1784 1785 1795 1797

    Distribution

    US Nationwide distribution.

    Quantity

    230 worldwide (64 US)