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Villa Sistemi Medicali S.P.A. recalls Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Produc
Recalled March 15, 2017 · FDA recall Z-1428-2017 · Villa Sistemi Medicali S.P.A
Hazard
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. · FDA Class II
Units
65 devices in total
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, PA, Puerto Rico, TN, TX, UT, and W.I
Description
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Product
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 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 →