# FDA recall Z-2616-2024

> **Biointellisense Inc.** · Class II · device recall initiated 2024-07-19.

## 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

- **Recall number:** Z-2616-2024
- **Recalling firm:** Biointellisense Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2616-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2616-2024. Source: US FDA. Licensed CC0.

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