Recall Z-0527-04 ยท IYX Camera, Scintillation (Gamma)
GVI Technology Partners
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
| Date | Feb 10, 2004 (initiated Jan 16, 2004) |
| Status | Terminated |
| Reason | Due to limitations in the operating software, the acquired scan may not be processed properly. |
| Root cause | Other |
| Action | The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit. |
| Quantity | 16 units |
| Distribution | One Single customer. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023373 | ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 Gvi Technology Partners, Jan 3, 2003 |