Z-1980-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2023
- Initiation Date
- May 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 in the U.S.
Product Description
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Reason for Recall
The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Code Information
Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.