Home / Recalls / PATH / Z-0401-2024

Z-0401-2024 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
15 units

Product Description

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

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: 04260223142437; Serial Numbers: 201015-201029

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-0404-2024 Class II — SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Numbe (September 26, 2023)
  • Z-0402-2024 Class II — SENTIERO Screening2, mobile medical devices for hearing examinations, Model Numb (September 26, 2023)