Device product
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Z-0988-2014
Product summary
- Event
- Event 67241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 738 units
- Official record key
device-enforcement:Z-0988-2014
Official wording
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 information: Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
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.