Recall Z-2616-2024 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Biointellisense Inc.
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.
| Date | Aug 14, 2024 (initiated Jul 19, 2024) |
| Status | Open, Classified |
| Reason | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |
| Root cause | Device Design |
| 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 |
| Quantity | 135,414 devices (U.S. 95,414 and O.U.S. 40,000) |
| Distribution | U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212957 | BioButton System Biolntellisense, Inc., Dec 12, 2022 |