Skip to content
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-1044-2017

January 10, 2017

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 76198
Status
Terminated
Classification
Class II
Quantity
1999
Official record key
device-enforcement:Z-1044-2017

Official wording

Reason: Incorrect dose after editing beam number an wedge angle.

Code information: Software Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00

Distribution pattern: AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect dose after editing beam number an wedge angle.