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Recall Observatory FDA recall evidence

Device product

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Z-1009-2017

December 21, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 76028
Status
Terminated
Classification
Class II
Quantity
279
Official record key
device-enforcement:Z-1009-2017

Official wording

Reason: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

Code information: Software Versions 5.00 and higher

Distribution pattern: Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.