Device recall
Z-2616-2024: BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a…
FDA device recall · Class II · Biointellisense Inc.
Key facts
| Recall number (Z-number) | Z-2616-2024 |
|---|---|
| Recall event | 94943 |
| Product | 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. |
| Product code | DRG |
| Recalling firm | Biointellisense Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212957 |
| FEI number | 3016592682 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database