Recall Z-0367-2014 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid 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
| Date | Nov 20, 2013 (initiated Oct 25, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a |
| Root cause | Employee error |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated September 25, 2013, to all affected customers. The letter identified the product the problem and the actions to be taken by the customer. We plan to correct all of the affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 systems that were distributed The plan for public warning is to contact all customers with an affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 system by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable m |
| Quantity | 464 (143 US, 321 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, |
| FDA record | Open on fda.gov |