Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Recall Z-0660-2017 · Posted None
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2016-11-03
Date Terminated2021-07-16
Product Quantity671
Reason for Recall
Incorrect Dose when using the reset function.
Firm Action
Important Field Safety Notice 382-01-MON-006 was sent to all affected customers on 11/3/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. An acknowledgement form was included which is to be returned to Elekta.
Root Cause
Software design
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,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.