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Recall Observatory FDA recall evidence

Device product

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

Z-1492-2014

December 04, 2013

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 67678
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1492-2014

Official wording

Reason: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).

Code information: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.

Distribution pattern: US Distribution including the states of OK, IL, NJ, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).