Device recall
Z-0674-03: ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following…
FDA device recall · Class II · Cti Pet Systems Inc
Key facts
| Recall number (Z-number) | Z-0674-03 |
|---|---|
| Recall event | 25710 |
| Product | ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL… |
| Product code | KPS |
| Recalling firm | Cti Pet Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2006 |
| 510(k) numbers | K002584, K913637, K920624, K940478, 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