Recall Z-2580-2018 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
| Date | May 24, 2018 |
| Status | Terminated |
| Reason | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). |
| Root cause | Component change control |
| Action | GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative. |
| Quantity | 42 units total |
| Distribution | Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161574 | Discovery MI Ge Medical Systems, LLC, Aug 11, 2016 |