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Biointellisense Inc. recalls BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device int
Recalled August 21, 2024 · FDA recall Z-2616-2024 · Biointellisense
Hazard
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. · FDA Class II
Units
135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Sold at
U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
Description
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Product
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.
Manufacturer(s)
Biointellisense Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →