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

Recall Z-0401-2024 — SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

U.S. FDA — Device Enforcement · Germany · 2023-09-26 · 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-0401-2024
Date of alert
2023-09-26
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
PATH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04260223142437
Reported risk: Affected lots of product may experience technical distortions to a greater extent than expected.
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.