Device recall
Z-0819-05: ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions…
FDA device recall · Class II · CTI PET Systems Inc
Key facts
| Recall number (Z-number) | Z-0819-05 |
|---|---|
| Recall event | 31770 |
| Product | ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America |
| Product code | KPS |
| Recalling firm | CTI PET Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2009 |
| 510(k) numbers | K002584, K003241, K962797 |
| 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