Recall Z-1394-04 ยท IYX Camera, Scintillation (Gamma)
General Electric Med Systems
SMV FX-80 Nuclear Camera
| Date | Aug 24, 2004 (initiated Jul 30, 2004) |
| Status | Terminated |
| Reason | The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out. |
| Root cause | Other |
| Action | The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector''s radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become lose, fail, or back out. |
| Quantity | 41 |
| Distribution | Inside the US. Manufactured and distributed from 1993 - 2000. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935273 | VISION FX 40 & 80 SERIES GAMMA CAMERA Summit Nuclear, Apr 18, 1994 |