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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-0660-2017

November 03, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 75664
Status
Terminated
Classification
Class II
Quantity
671
Official record key
device-enforcement:Z-0660-2017

Official wording

Reason: Incorrect Dose when using the reset function.

Code information: Software Builds 5.11 and 5.20

Distribution pattern: AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect Dose when using the reset function.