BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intend
FDA device recall Z-2616-2024 · posted 2024-08-14 · Open, Classified
Recall details
- Recalling firm
- Biointellisense Inc.
- Reason for recall
- Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DRG
- Quantity affected
- 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
- Date initiated
- 2024-07-19
- Date posted
- 2024-08-14
- Location
- Redwood City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BioButton System (K212957) | Biolntellisense, Inc. | 2022-12-12 |