Home / Recalls / PATH / Z-0402-2024

Z-0402-2024 Class II Ongoing

Recalled by PATH — Germering

Recall Details

Product Type
Devices
Report Date
December 6, 2023
Initiation Date
September 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 units

Product Description

SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

Reason for Recall

Affected lots of product may experience technical distortions to a greater extent than expected.

Distribution Pattern

US States: FL, MO, OH, WI

Code Information

UDI-DI: 04260223145377; Serial Numbers: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 290446

Other recalls by PATH

  • Z-0940-2026 Class II — MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) (November 6, 2025)
  • Z-0403-2024 Class II — AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH10009 (September 26, 2023)
  • Z-0401-2024 Class II — SENTIERO, mobile medical devices for hearing examinations, Model Number SOH10009 (September 26, 2023)
  • Z-0404-2024 Class II — SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Numbe (September 26, 2023)