Events

Recall of Device Recall Siemens Hearing Instruments Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Hearing Instruments, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67241
  • Event Risk Class
    Class 2
  • Event Number
    Z-0988-2014
  • Event Initiated Date
    2005-07-01
  • Event Date Posted
    2014-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125067
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Aids, speech training for the hearing impaired (ac-powered and patient-contact) - Product Code LEZ
  • 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.

Device

Device Recall Siemens Hearing Instruments Inc.
  • Model / Serial
    Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Siemens Prisma 2K Hearing Aid || Product Usage: || A behind the ear (BTE) hearing aid developed for pediatric patients.
  • Manufacturer
    Siemens Hearing Instruments, Inc

Manufacturer

Siemens Hearing Instruments, Inc
  • Manufacturer Address
    Siemens Hearing Instruments, Inc, 10 Constitution Ave, Piscataway NJ 08855
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA