Device recall
Z-0527-04: CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with…
FDA device recall · Class III · GVI Technology Partners
Key facts
| Recall number (Z-number) | Z-0527-04 |
|---|---|
| Recall event | 28161 |
| Product | CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech. |
| Product code | IYX |
| Recalling firm | GVI Technology Partners |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 12, 2012 |
| 510(k) numbers | K023373 |
| FEI number | 3003917438 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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