Device product
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.
Z-0934-2018
Product summary
- Event
- Event 79231
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-0934-2018
Official wording
Reason: An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Code information: PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (US).
Distribution pattern: US Distribution to the states of : MA, FL, VA, PA, OK, TN
Derived failure modes
-
Unknown
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.