FDA-Device2013-05-08Class II
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
GE Healthcare, LLC
Hazard
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Sold states
Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
Affected count
81
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2013Don't want to check this manually?
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