Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for...

FDA Recall #Z-0988-2014 — Class II — July 1, 2005

Recall #Z-0988-2014 Date: July 1, 2005 Classification: Class II Status: Terminated

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.

Recalling Firm

Siemens Hearing Instruments, Inc — Piscataway, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

738 units

Distribution

USA Nationwide Distribution

Code Information

Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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