Device product
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Z-1205-2022
Product summary
- Event
- Event 90213
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1205-2022
Official wording
Reason: First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Code information: UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
Derived failure modes
-
Unknown
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed