Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0261-2018