Device recall
Z-0855-2009: Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF)…
FDA device recall · Class II · Varian Medical Systems Oncology Systems
Key facts
| Recall number (Z-number) | Z-0855-2009 |
|---|---|
| Recall event | 50143 |
| Product | Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye. |
| Product code | MUJ |
| Recalling firm | Varian Medical Systems Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2010 |
| 510(k) numbers | K071873 |
| FEI number | 2916710 |
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