Biointellisense Inc.: Device Recall
Recall #Z-2616-2024 · 07/19/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2616-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Biointellisense Inc.
- Status
- Ongoing
- Date Initiated
- 07/19/2024
- Location
- Redwood City, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Reason for Recall
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
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.
Distribution Pattern
U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.