Device recall
Z-3101-2011: On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline…
FDA device recall · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Recall number (Z-number) | Z-3101-2011 |
|---|---|
| Recall event | 59262 |
| Product | On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2012 |
| 510(k) numbers | K042720, K092871 |
| 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