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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Hearing Instruments Inc.

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  Class 2 Device Recall Siemens Hearing Instruments Inc. see related information
Date Initiated by Firm July 01, 2005
Date Posted February 18, 2014
Recall Status1 Terminated 3 on July 06, 2017
Recall Number Z-0988-2014
Recall Event ID 67241
Product Classification Aids, speech training for the hearing impaired (ac-powered and patient-contact) - Product Code LEZ
Product Siemens Prisma 2K Hearing Aid

Product Usage:
A behind the ear (BTE) hearing aid developed for pediatric patients.
Code Information Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Recalling Firm/
Siemens Hearing Instruments, Inc
10 Constitution Ave
Piscataway NJ 08855
For Additional Information Contact Mr. John Schirado
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 738 units
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.