Device recall
Z-2225-2009: Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-2225-2009 |
|---|---|
| Recall event | 50528 |
| Product | Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications. |
| Product code | JAK |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2016 |
| 510(k) numbers | K913485, K921192 |
| FEI number | 2126677 |
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