Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
This recall has been terminated (originally issued October 28, 2005).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- September 27, 2005
- Posted
- October 28, 2005
- Terminated
- December 26, 2006
- Recall Number
- Z-0105-06
- Quantity
- 140 (80 US and 60 OUS)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.