FDA-Device2017-03-15Class II
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
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.
Sold states
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
Affected count
65 devices in total
Manufactured in
Via delle Azalee 3, N/A, Buccinasco, N/A, Italy
Products
Apollo EZ; Model: 9784152036 Product Usage: 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-1430-2017Don't want to check this manually?
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