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Recall Observatory FDA recall evidence

Device product

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Z-0938-2018

November 17, 2017

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 79230
Status
Terminated
Classification
Class II
Quantity
37
Official record key
device-enforcement:Z-0938-2018

Official wording

Reason: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

Code information: PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.