Device recall
Z-0282-2021: Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web…
FDA device recall · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Recall number (Z-number) | Z-0282-2021 |
|---|---|
| Recall event | 86494 |
| Product | Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. |
| Product code | LLZ |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2021 |
| 510(k) numbers | K190232 |
| FEI number | 1000513161 |
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