Ion Beam Applications S.A.

Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126, SBF.101

Radiology Devices

2

No

Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

Proteus ONE and Proteus Plus

Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126, SBF.101

Radiology Devices

2

No

Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

12C

Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101

Radiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.

12C (AdaPTinsight) || Affected component: AdaPTinsight software || Product Usage: || 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

PAT.003 (KR), PAT.006 (US)

Radiology Devices

2

No

US Distribution to the state of :FL

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X || The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.

PAT.115, SAT.116

Radiology Devices

2

No

WA

Proteus 235, graphite block 8