Device product
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.
Z-2684-2017
Product summary
- Event
- Event 77621
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 worldwide and 5 in the U.S.
- Official record key
device-enforcement:Z-2684-2017
Official wording
Reason: Software issue
Code information: Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003
Distribution pattern: Distributed to FL, VA, IL, NJ, WA and South Korea
Derived failure modes
-
Device software or design
Software issue