SMV FX-40 Nuclear Camera
FDA device recall Z-1393-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYX
- Quantity affected
- 65
- Distribution
- Inside the US. Manufactured and distributed from 1993 - 2000.
- Date initiated
- 2004-07-30
- Date posted
- 2004-08-24
- Date terminated
- 2006-07-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISION FX 40 & 80 SERIES GAMMA CAMERA (K935273) | Summit Nuclear | 1994-04-18 |