The Recall Desk
HighFDA (Devices)·Z-0988-2014·Announced 2014-02-26

Siemens Prisma 2K Pediatric Hearing Aid Battery Compartment Recall

Siemens is recalling Prisma 2K hearing aids because the battery compartment may open under unintended use, posing a risk to infants and children.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (pediatric hearing aid with accessible battery compartment) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Hearing Instruments, Inc. is recalling 738 units of the Prisma 2K behind-the-ear (BTE) hearing aid. This device was developed specifically for pediatric patients. The recall covers units distributed nationwide in the United States.

The recall was initiated because Siemens identified an issue where an infant or child could open the tamper-resistant battery compartment under certain unintended use conditions. This defect creates a potential safety hazard for the intended pediatric user base.

Consumers who possess this product should stop using it immediately. Affected units can be identified by the following part numbers: 7773182, 7244028, 8757374, 8747086, 10056937, or 10056938. Users should contact Siemens Hearing Instruments, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Manufacturer
Siemens Hearing Instruments, Inc
Category
Medical Device — Hearing Aid
Hazard
Affected units
738

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · battery ingestion

See all →