FDA recall Z-0747-2022

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

Product

ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235

Reason for recall

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

Distribution

IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,

Key facts

Status
Ongoing
Initiation date
2022-02-15
Report date
2022-03-16
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-0747-2022