Device recall
Z-0159-2011: Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured…
FDA device recall · Class II · Impac Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0159-2011 |
|---|---|
| Recall event | 55712 |
| Product | Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. |
| Product code | MUJ |
| Recalling firm | Impac Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2011 |
| 510(k) numbers | K981313 |
| FEI number | 1000123805 |
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