General Electric Med Systems LLC Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
which was subsequently acquired by GE Healthcare in 2000.
Products Sold
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.
General Electric Med Systems LLC is recalling Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System due to 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 contin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, DE, FL, GA, IL, IA, KS, MD, MA, MI, NJ, NY, NC, OH, PA, SC, TX, VA, WV, WI
Page updated: Jan 10, 2026