Ion Beam Applications S.A.: Medical Device Recall in 2017 - (Recall #: Z-2684-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 13, 2016

Date Posted: July 12, 2017

Recall Number: Z-2684-2017

Event ID: 77621

Reason for Recall:

Software issue

Status: Terminated

Product Quantity: 6 worldwide and 5 in the U.S.

Code Information:

Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated