SenTec AG: V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

Hazard

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.

Details from the source

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: US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX. Quantity: 11 in the U.S. Lot/code info: Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.

UPC codes

07640121880513

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.