Device recall
Z-1163-2013: Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option…
FDA device recall · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Recall number (Z-number) | Z-1163-2013 |
|---|---|
| Recall event | 64828 |
| Product | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion. |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 9, 2014 |
| 510(k) numbers | K102024 |
| 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