Z-1205-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- April 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
Code Information
UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).