FDA recall Z-0401-2024

Product

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

US States: FL, MO, OH, WI

Key facts

Status

Ongoing

Initiation date

2023-09-26

Report date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germering, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2024