BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0988-2014 · Initiated July 1, 2005

    Recall

    Recall Number
    Z-0988-2014
    Event Number
    67241
    Firm
    Siemens Hearing Instruments, Inc
    FEI Number
    2217809
    Product Code
    LEZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 1, 2005
    Posted
    February 18, 2014
    Terminated
    July 6, 2017
    Address
    10 Constitution Ave, Piscataway, NJ, 08855

    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.

    Action

    Siemens sent a notice letter to affected customers in 7/2005 and 12/2005. The letter identified the affected product, problem and actions to be taken. Siemens will install an additional security measure to affected product at no charge. For questions contact your Sales Representative at 800-766-4500.

    Distribution

    USA Nationwide Distribution

    Quantity

    738 units