Device product
Proteus 235 Product Usage: 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-0698-2019
Product summary
- Event
- Event 81807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-0698-2019
Official wording
Reason: There is a risk of detachment of the Compact Gantry Rolling Floor.
Code information: SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109
Distribution pattern: Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
Derived failure modes
-
Unknown
There is a risk of detachment of the Compact Gantry Rolling Floor.