Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Company
- Elekta, Inc.
- Recall Initiated
- November 3, 2016
- Terminated
- July 16, 2021
- Recall Number
- Z-0660-2017
- Quantity
- 671
- Firm Location
- Atlanta, GA
Reason for Recall
Incorrect Dose when using the reset function.
Distribution
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,
Lot / Code Info
Software Builds 5.11 and 5.20
Root Cause
Software design
Action Taken
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.