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Villa Radiology Systems LLC recalls Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs a
Recalled September 25, 2013 · FDA recall Z-2160-2013 · Villa Radiology Systems
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 · FDA Class II
Units
22 units within US
Sold at
US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.
Description
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
Product
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Manufacturer(s)
Villa Radiology Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →