FDA recall Z-2684-2017

Product

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Reason for recall

Software issue

Distribution

Distributed to FL, VA, IL, NJ, WA and South Korea

Key facts

Status

Terminated

Initiation date

2016-12-13

Report date

2017-07-12

Termination date

2019-04-12

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-2684-2017