Device recall
Z-2581-2021: AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08…
FDA device recall · Class II · Biodex Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2581-2021 |
|---|---|
| Recall event | 88604 |
| Product | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332 |
| Product code | KPT |
| Recalling firm | Biodex Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2024 |
| 510(k) numbers | K090296 |
| FEI number | 2431314 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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