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FDAFDA · Food and drugs·Recall number Z-0988-2014

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

Published February 26, 2014 · Recall initiated: July 1, 2005

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Siemens Hearing Instruments, Inc
Distributor
USA Nationwide Distribution
Lot
Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Risk classification
Class II
Area (FDA)
device
Country
United States

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