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Recall Observatory FDA recall evidence

Device product

Proteus 235 and Proteus ONE proton therapy systems

Z-2672-2017

May 18, 2016

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 77620
Status
Terminated
Classification
Class II
Quantity
18 worldwide and 10, in the U.S.
Official record key
device-enforcement:Z-2672-2017

Official wording

Reason: Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

Code information: Code/Serial Numbers: 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 and SAT.126

Distribution pattern: Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.