Medical Device Recall: 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 set
Biointellisense Inc. · July 19, 2024
Reason for Recall
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Product Description
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.
Distribution
U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
States Affected
CA, CO, MA, TN, TX
Quantity Affected
135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2616-2024
Status: ongoing
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