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Recall Observatory FDA recall evidence

Device product

Proteus 235, graphite block 8

Z-0930-2018

October 17, 2017

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 79227
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0930-2018

Official wording

Reason: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

Code information: PAT.115, SAT.116

Distribution pattern: WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader