#DST VISION SERIAL NUMBERS#

The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.

OUS to include: Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Greece, Italy, Korea, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sinapore, Spain, Sweden and United Kingdomġ A record in this database is created when a firm initiates a correction or removal action. 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. This letter describes the potential hazard, its waring signs and the additional corrective actions that will be taken by GE Healthcare. GE Healthcare issued an Urgent Safety Notice, dated 07/22/05, to all affected sites. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000.Ĭracked 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. The label is located on the inner side of the gantry cover.

#DST VISION SERIAL NUMBERS#

STATIF DST and STATIF DST-XL model 100, serial numbers 001-264.

Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging SystemĬameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. System, Tomography, Computed, Emission - Product Code KPS Class 2 Device Recall Sopha Medical Vision DST / DSTXL Nuclear Cameras

Dst vision