BioButton REF BIOST06040 with Software version 3.0.20 Th... (Biointellisense Inc. 570 El Camino Real) – software anomaly causing the skin tem... (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

On 07/19/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them of a software anomaly that may cause the skin temperature accuracy to be slightly out of specification. Customers are instructed to: - (For customers who wish to receive remote firmware update/fix) Notify clinical staff of the issue as well as the updated skin temperature accuracy for the Affected Product - (For customers who do not wish to receive remote firmware update/fix) Please stop use of the Affected Devices and return them to BioIntelliSense, where possible. Notify or make aware all clinical staff of the recall issues and notify any additional facilities where the Affected Devices may have been further transferred. For questions or assistance - contact BioIntelliSense Customer Support at 888.908.8804 or email address - support@biointellisense.com

Distribution

As reported by FDA

CA, CO, MA, TN, TX