MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV; and to countries of:: Australia, Canada, China, Dominican Republic, Hong Kong, India, Japan, Korea, Malaysia, Mexico, Pakistan, Panama, Peru, Singapore, Sri Lanka, Taiwan, and Thailand.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2018