Recall Z-0988-2014 ยท LEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Siemens Hearing Instruments, Inc
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
| Date | Feb 18, 2014 (initiated Jul 1, 2005) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 738 units |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.