Device recall
Z-0588-06: Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog…
FDA device recall · Class II · General Electric Med Systems LLC
Key facts
| Recall number (Z-number) | Z-0588-06 |
|---|---|
| Recall event | 34935 |
| Product | Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology… |
| Product code | KPS |
| Recalling firm | General Electric Med Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2006 |
| 510(k) numbers | K042257 |
| 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