FDA recall Z-2155-2021

Ion Beam Applications S.A. · Class II · device

Product

Proteus 235-Proton Therapy System

Reason for recall

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

Distribution

FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands

Key facts

Status: Ongoing
Initiation date: 2021-05-26
Report date: 2021-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Louvain-la-neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2155-2021