The kits were recalled due to the potential for the tube connector to dislodge, which may result in disconnection of the patient from the breathing circuit.
The soft and conformable monitor can broadcast ECG, heart/respiratory rate, and motion activity data as much as 15 meters to a portable recording device.
The agency believes that additional changes are needed to fully modernize the 510(k) program.
Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration04.30.19