Device evidence

device-recall:cfres:192319

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

Official recall number

Z-0747-2022

Evidence summary

Product code: LHN
Recall status: Open, Classified
Event initiated: February 15, 2022
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0747-2022