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Ion Beam Applications S.A. recalls Proteus 235-Proton Therapy System
Recalled August 4, 2021 · FDA recall Z-2155-2021 · Ion Beam Applications S.A
Hazard
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position · FDA Class II
Units
5 US; 8 OUS
Sold at
FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Description
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Product
Proteus 235-Proton Therapy System
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →