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Recall Observatory FDA recall evidence

Device product

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621

Z-0745-2016

January 08, 2016

Class II

Product summary

Firm
Philips Medical Systems
Event
Event 73023
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0745-2016

Official wording

Reason: In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.

Code information: Software Version 10.0.0 and 14.0.0

Distribution pattern: US: Nationwide Distribution in the states of FL, OH, and MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.