Biointellisense Inc. recalls BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device inten…

Recall date

July 19, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2616-2024

FDA classification

Class II

Brand / firm

Biointellisense Inc.

Sold / distributed

U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided

Why it was recalled

Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.