Device recall
Z-0142-2027: NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part…
FDA device recall · Class II · Neuronetics, Inc.
Key facts
| Recall number (Z-number) | Z-0142-2027 |
|---|---|
| Recall event | 99812 |
| Product | NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number… |
| Product code | OBP |
| Recalling firm | Neuronetics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K231926, K233621 |
| FEI number | 3004824012 |
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