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Recall Observatory FDA recall evidence

Device product

Radiation Therapy Treatment Planning System, Model 5.0

Z-0079-2017

May 30, 2016

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 74750
Status
Terminated
Classification
Class II
Quantity
491 units (187 domestically & 304 internationally)
Official record key
device-enforcement:Z-0079-2017

Official wording

Reason: For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.

Code information: 5.0.0.37, 5.0.1.11 and 5.0.2.35

Distribution pattern: AZ, CA, FL, MT, NC NY, TX, OH & WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.