Recall Z-0606-2019 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
| Date | May 24, 2018 |
| Status | Completed |
| Reason | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard. |
| Root cause | Component change control |
| Action | The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired. |
| Quantity | 4 units |
| Distribution | CA, DC, OH, UT, WI, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093514 | DISCOVERY MODEL NM/CT 670 Ge Medical Systems F.I. Haifa, Dec 10, 2009 |