FDA-Device2014-02-26Class II
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Siemens Hearing Instruments, Inc
Hazard
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.
Sold states
USA Nationwide Distribution
Affected count
738 units
Manufactured in
10 Constitution Ave, Piscataway, NJ, United States
Products
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0988-2014Don't want to check this manually?
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