FDA recall Z-2616-2024

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 for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-07-19

Report date

2024-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redwood City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2616-2024