Recall Z-0988-2014— Siemens Hearing Instruments, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Hearing Instruments, Inc, initiated 2005-07-01, terminated 2017-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.. 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..
- Recalling firm
- Siemens Hearing Instruments, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2005-07-01
- Terminated
- 2017-07-06
- Firm location
- Piscataway, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.