Device recall
Z-2103-2008: Radiation therapy system - Coherence Therapist System 2.1 equipped with…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-2103-2008 |
|---|---|
| Recall event | 48439 |
| Product | Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147667. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO… |
| 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