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Recall Observatory FDA recall evidence

Device product

Monaco Radiation Treatment Planning (RTP) System

Z-0965-2019

February 08, 2019

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 82072
Status
Terminated
Classification
Class II
Quantity
14 devices
Official record key
device-enforcement:Z-0965-2019

Official wording

Reason: If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

Code information: Software version 5.40

Distribution pattern: Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.