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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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