FDA Device

Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System

Hazard

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.

What You Should Do

Remedy

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.

Products

Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
Brand
General Electric Med Systems LLC
UPC
Cameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. STATIF DST and STATIF DST-XL model 100, serial numbers 001-264. The label is located on the inner side of the gantry cover. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000.

Units Affected

140 (80 US and 60 OUS)