Device product
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Z-0403-2024
Product summary
- Firm
- PATH
- Event
- Event 93275
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-0403-2024
Official wording
Reason: Affected lots of product may experience technical distortions to a greater extent than expected.
Code information: UDI-DI: 04260223143298; Serial Numbers: 260446-260468
Distribution pattern: US States: FL, MO, OH, WI
Derived failure modes
-
Unknown
Affected lots of product may experience technical distortions to a greater extent than expected.