FDAJuly 19, 2024device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
What to do
FDA enforcement status: Ongoing
Brands named
biointellisense
UPCs
00850005949299
Recall history
No related federal recalls on record for this brand yet.
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