Z-0402-2024 Class II Ongoing
FDA device recall Z-0402-2024 was initiated by PATH on Sep 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: 28 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 6, 2023
- Initiation Date
- Sep 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
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.
Distribution pattern
US States: FL, MO, OH, WI
Code information
UDI-DI: 04260223145377; Serial Numbers: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 290446
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0402-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026