Device recall
Z-1138-2019: IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that…
FDA device recall · Class II · Topcon Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1138-2019 |
|---|---|
| Recall event | 82322 |
| Product | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of… |
| Product code | NFJ |
| Recalling firm | Topcon Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2019 |
| 510(k) numbers | K171370 |
| FEI number | 2242863 |
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