Recall Z-2616-2024— Biointellisense Inc.
Class II · Ongoing
Class II FDA medical device recall by Biointellisense Inc., initiated 2024-07-19. It names one FDA 510(k) clearance: K212957. 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.. Reason: Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification..
- Recalling firm
- Biointellisense Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-19
- Firm location
- Redwood City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.