Recall Z-1279-2015 ยท KPS System, Tomography, Computed, Emission
GE Healthcare
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image
| Date | Mar 13, 2015 (initiated Mar 5, 2015) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date |
| Root cause | Use error |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 40865 dated March 5, 2015. The letter was addressed to Managers of Nuclear Medecine, Hospital Administrators / Risk Managers and Managers of Radiology /Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact in the United States: 1-800-437-1171. For other countries, contact your local GE Healthcare Service Representative. |
| Quantity | 472 (127 units US, 345 units OUS) |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NY, NC, OK, PA, PR, SD, TN, TX, VA, WA, WV, WI. and the countries of URUGUAY, UNITED KINGDOM,UKRAINE, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVAKIA, RUSSIA,PORTUGA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953801 | VARICAM Elscint, Inc., Nov 22, 1995 |