FDA-Device2024-08-21Class II
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
Biointellisense Inc.
Hazard
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Sold states
U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
Affected count
135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Manufactured in
570 El Camino Real Ste 200, Redwood City, CA, United States
Products
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2616-2024Don't want to check this manually?
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