FDA recall Z-0938-2018

Product

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Reason for recall

There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2018-03-21

Termination date

2021-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louvain La Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2018