FDA-Device2013-09-25Class II
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Radiology Systems LLC
Hazard
It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
Sold states
US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.
Affected count
22 units within US
Manufactured in
91 Willenbrock Rd Ste B1, N/A, Oxford, CT, United States
Products
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2013Don't want to check this manually?
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