Device recall
Z-0952-2021: Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product…
FDA device recall · Class II · Topcon Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0952-2021 |
|---|---|
| Recall event | 87086 |
| Product | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information. |
| Product code | NFJ |
| Recalling firm | Topcon Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 19, 2022 |
| FEI number | 2242863 |
At a glance
- None 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