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Villa Sistemi Medicali S.P.A. recalls Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and
Recalled January 8, 2020 · FDA recall Z-0763-2020 · Villa Sistemi Medicali S.P.A
Hazard
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years. · FDA Class II
Units
46
Sold at
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.
Description
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Product
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Manufacturer(s)
Villa Sistemi Medicali S.P.A.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →