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Recall Observatory FDA recall evidence

Device product

Proteus 235 The PTS 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-2173-2018

August 07, 2016

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 80222
Status
Terminated
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-2173-2018

Official wording

Reason: IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

Code information: Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126.

Distribution pattern: Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.