Device Recall ProteusPLUS

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

Radiology Devices

2

No

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

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.

PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)

Radiology Devices

2

No

Nationally

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.

PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (US).

Radiology Devices

2

No

US Distribution to the states of : MA, FL, VA, PA, OK, TN

Proteus 235, Uniform and Pencil Beam Scanning || 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.

Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)

Radiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands

Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 || Product Usage: || A 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.