Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0988-2014 — Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.

U.S. FDA — Device Enforcement · United States · 2005-07-01 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0988-2014
Date of alert
2005-07-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Hearing Instruments, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10056937
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.