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U.S. Department of Health and Human Services

Class 2 Device Recall Sopha Medical Vision DST / DSTXL Nuclear Cameras

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  Class 2 Device Recall Sopha Medical Vision DST / DSTXL Nuclear Cameras see related information
Date Initiated by Firm September 27, 2005
Date Posted October 28, 2005
Recall Status1 Terminated 3 on December 26, 2006
Recall Number Z-0105-06
Recall Event ID 33832
510(K)Number K942837  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
Code Information 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.
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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, Sweden and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = SOPHA MEDICAL SYSTEMS, INC.
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