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.
FDA Recall Z-2616-2024 · Posted 2024-08-14
Advertisement
Recalling FirmBiointellisense Inc.
Recall StatusOpen, Classified
Product CodeDRG
Date Initiated2024-07-19
Product Quantity135,414 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.
Firm Action
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 - [email protected]
Root Cause
Device Design
Distribution Pattern
U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement