Device recall
Z-0945-2011: GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice)…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0945-2011 |
|---|---|
| Recall event | 57193 |
| Product | GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. |
| Product code | JAK |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2012 |
| FEI number | 2126677 |
At a glance
- None 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