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Fx Solutions recalls Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton be
Recalled July 25, 2018 · FDA recall Z-2469-2018 · Fx Solutions
Hazard
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. · FDA Class II
Units
145 units
Sold at
Worldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland
Description
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Product
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Manufacturer(s)
Fx Solutions
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →