FDA warning letter · Medical Devices

Omnisense Systems Pte Ltd.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

From H1N1, MERS, Ebola and now COVID-19, our fever detection system have been the trusted solution to secure critical installations and national borders.

Passage 2

Drawing on our proven performance of Sentry MK3, the system that protected many organizations and institutions from H5N1 to COVID-19, the Sentry MK4 is a culmination of more than a decade experience of developing a remarkable fever screening system.

Passage 3

At the forefront of pandemic defence, the Sentry MK4 Mass Fever Screening System stands guard against infectious diseases and viruses. Already deployed in commercial buildings, industrial plants, airports, hospitals, banks and other critical facilities, the Sentry MK4 is an essential security solution for any modern organization seeking to safeguard human assets and sustain business operations during a pandemic outbreak.

Passage 4

The Sentry MK4 is offered for sale in the United States without marketing approval, clearance, or authorization from FDA.

Passage 5

Mass Fever Screening System

Passage 6

Sentry MK4 – Mass Fever Screening System scans, detects and tracks febrile persons with elevated skin temperature at any venue with large human traffic