Device product

Proteus 235, Proton Therapy System

Z-1830-2017

March 21, 2017

Class II

Product summary

Firm: Ion Beam Applications S.A.
Event: Event 76804
Status: Terminated
Classification: Class II
Quantity: 2 worldwide, 1 in U.S.
Official record key: device-enforcement:Z-1830-2017

Official wording

Reason: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

Code information: Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

Distribution pattern: Distribution in US (to Louisiana), and France.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.