O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

Recall details

Manufacturer

Medtronic Navigation, Inc.-Littleton

Distributor

Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countries: Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Venezuela.

Lot

All Serial Numbers

Risk classification

Class II

Area (FDA)

device

Country

United States