Company: Biointellisense Inc.
Date of Enforcement Report: 8/14/2024
Class II
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.
Recall Number:
Z-2616-2024
REASON:
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
RECALLING FIRM/MANUFACTURER:
Biointellisense Inc.
VOLUME OF PRODUCT IN COMMERCE:
135,414 devices (U.S. 95,414 and O.U.S. 40,000)
DISTRIBUTION:
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.
