Device recall
Z-1050-2023: NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot…
FDA device recall · Class II · NovaSignal Corp.
Key facts
| Recall number (Z-number) | Z-1050-2023 |
|---|---|
| Recall event | 91467 |
| Product | NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1) |
| Product code | IYN |
| Recalling firm | NovaSignal Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160442 |
| FEI number | 3013368530 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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