BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.

    Recall: Z-0988-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0988-2014
    Event ID
    67241
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Hearing Instruments, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    July 1, 2005
    Classification Date
    February 18, 2014
    Termination Date
    July 6, 2017
    Address
    10 Constitution Ave, Piscataway, NJ, 08855, United States

    Description

    Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.

    Reason

    Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.

    Code Info

    Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938

    Distribution

    USA Nationwide Distribution

    Quantity

    738 units