Aug

2024

FDA Recall: Software Anomaly Causing Inaccurate Temperature Measurements

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:

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Anomaly Causing Inaccurate Temperature Measurements

Allison Pate

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