GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.
Hazard
Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr.
What You Should Do
Remedy
GE Healthcare will notify purchasers of the problem, the affected product, instructions for users, and specify the maximum emission rate measured. GE Healthcare will bring defective systems into compliance free of charge. This will be done via Field Modification Instructions IFMI) 11101 which is scheduled for deployment on March 1, 2011 with an estimated completion date of July 1, 2011.
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Products
GE eXplore Locus Micro CT cabinet x-ray system model RS9-80.
CT Scanner for laboratory mice or other research.
- Brand
- GE Healthcare, LLC
- UPC
- Part Number 5134163.
Units Affected
21