Device recall
Z-2095-2008: Radiation therapy system - Coherence AG Therapist Part number 5863506 and…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-2095-2008 |
|---|---|
| Recall event | 48439 |
| Product | Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system Part number 7339125, equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1. This is a medical charged particle radiation therapy system, part of the firm's beam limiting device/accessory. The product… |
| Product code | IYE |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2010 |
| 510(k) numbers | K060226 |
| FEI number | 2937457 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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