Day

August 14, 2024
14
Aug

FDA Recall: Software Anomaly Causing Inaccurate Temperature Measurements

August 14, 2024
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...
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