Z-0988-2014 Class II Terminated
FDA device recall Z-0988-2014 was initiated by Siemens Hearing Instruments, Inc on July 1, 2005 and is designated Class II. 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. The recall status is terminated (terminated July 6, 2017). Affected quantity: 738 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2014
- Initiation Date
- July 1, 2005
- Termination Date
- July 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 738 units
Product Description
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
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.
Distribution Pattern
USA Nationwide Distribution
Code Information
Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938