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Recall Observatory FDA recall evidence

Device product

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

Z-2712-2016

August 18, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 74961
Status
Terminated
Classification
Class II
Quantity
3,012 units
Official record key
device-enforcement:Z-2712-2016

Official wording

Reason: In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

Code information: Software 3.1 and higher.

Distribution pattern: Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Nambia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.