Recall Z-0703-2019 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Discover VH/Millennium VG Nuclear Medicine Imaging System
| Date | Oct 30, 2017 |
| Status | Completed |
| Reason | A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan. |
| Root cause | Other |
| Action | The firm initiated the medical device correction by letter on 10/0/2017. The letter instructed the consignee to ensure the collimator locking handles are in the locked position at all times. GE Healthcare will inspect and if necessary correct all affected products. |
| Quantity | 339 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953801 | VARICAM Elscint, Inc., Nov 22, 1995 |