Recall Z-0105-06 ยท KPS System, Tomography, Computed, Emission
General Electric Med Systems LLC
Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
| Date | Oct 28, 2005 (initiated Sep 27, 2005) |
| Status | Terminated |
| Reason | Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured. |
| Root cause | Other |
| Action | GE Healthcare issued an Urgent Safety Notice, dated 07/22/05, to all affected sites. This letter describes the potential hazard, its waring signs and the additional corrective actions that will be taken by GE Healthcare. |
| Quantity | 140 (80 US and 60 OUS) |
| Distribution | Within the US to include: AL, AZ, CA, DE, FL, GA, IA, IL, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, VA, WI and WV. OUS to include: Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Greece, Italy, Korea, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sinapore, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942837 | DST-XL Sopha Medical Systems, Inc., Jan 5, 1995 |