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BioButton (Reprocessed, NF Version)
BIOINTELLISENSE, INC. · Model BBR-B-I-R (BBR-B-NF-I-R) · UDI-DI 00850005949565
10
510(k) clearances
1,726
Adverse events (73 deaths)
12
Recalls
126
Facilities
Description
The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. Note: this model is reprocessed device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2024-07-19 | Biointellisense Inc. | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |
| 2021-01-08 | Nihon Kohden America Inc | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| 2020-05-21 | Vitalconnect Inc. | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was f |
| 2017-05-15 | Boston Scientific Corporation | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. |
| 2017-03-02 | Philips Visicu | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological device |
| 2016-03-10 | Philips Visicu | The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the |
| 2012-02-24 | BRAEMAR, INC. | Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. Th |
| 2011-05-02 | BRAEMAR, INC. | Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result i |
| 2007-12-13 | Lifesync Corporation | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.