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[Recalled] Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients. — Siemens became aware of an issue where an infant or child could open the tamper… | FDA 2005-07-01

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductSiemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Brand / manufacturerSiemens Hearing Instruments, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0988-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date01 July 2005
EAN / barcode10056937

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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