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Recall Observatory FDA recall evidence

Device product

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

Z-1980-2023

May 02, 2023

Class II

Product summary

Firm
SenTec AG
Event
Event 92355
Status
Ongoing
Classification
Class II
Quantity
11 in the U.S.
Official record key
device-enforcement:Z-1980-2023

Official wording

Reason: 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.

Code information: Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.

Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    failure because after recalibration, the sensors stayed in the software