FDA Enforcement
Class II
Ongoing
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Recall: Z-0404-2024
·
Reported December 6, 2023
Enforcement
- Recall Number
- Z-0404-2024
- Event ID
- 93275
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PATH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 6, 2023
- Initiation Date
- September 26, 2023
- Classification Date
- November 24, 2023
- Address
- Landsberger Str. 65, Germering, N/A, Germany
Description
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Reason
Affected lots of product may experience technical distortions to a greater extent than expected.
Code Info
UDI-DI: 04260223142475; Serial Numbers: 280117
Distribution
US States: FL, MO, OH, WI
Quantity
1 unit