Device recall
Z-1846-2014: ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy…
FDA device recall · Class II · VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Key facts
| Recall number (Z-number) | Z-1846-2014 |
|---|---|
| Recall event | 68384 |
| Product | ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated. |
| Product code | LHN |
| Recalling firm | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2014 |
| 510(k) numbers | K133191 |
| FEI number | 3008889206 |
At a glance
- 1–9 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