Device recall
Z-0547-05: PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron…
FDA device recall · Class II · CTI PET Systems Inc
Key facts
| Recall number (Z-number) | Z-0547-05 |
|---|---|
| Recall event | 30802 |
| Product | PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT |
| Product code | KPS |
| Recalling firm | CTI PET Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2008 |
| 510(k) numbers | K002715, K013504, K023518, K033431, K042467 |
| FEI number | 1034973 |
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