Z-0401-2024 Class II Ongoing
FDA device recall Z-0401-2024 was initiated by PATH on September 26, 2023 and is designated Class II. Reason for recall: Affected lots of product may experience technical distortions to a greater extent than expected. The recall status is ongoing. Affected quantity: 15 units.
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