FDA recall Z-0403-2024

PATH · Class II · device

Product

AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

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-0403-2024