PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 6, 2023 Initiated: September 26, 2023 #Z-0402-2024

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.

Details

Recalling Firm
PATH
Units Affected
28 units
Distribution
US States: FL, MO, OH, WI
Location
Germering

Frequently Asked Questions

What product was recalled?
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2. Recalled by PATH. Units affected: 28 units.
Why was this product recalled?
Affected lots of product may experience technical distortions to a greater extent than expected.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 6, 2023. Severity: Moderate. Recall number: Z-0402-2024.