Device recall
Z-1027-2011: SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds)…
FDA device recall · Class II · Impac Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1027-2011 |
|---|---|
| Recall event | 52903 |
| Product | SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment… |
| Product code | IYE |
| Recalling firm | Impac Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 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