Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Company
- Elekta, Inc.
- Recall Initiated
- January 10, 2017
- Terminated
- August 18, 2020
- Recall Number
- Z-1044-2017
- Quantity
- 1999
- Firm Location
- Atlanta, GA
Reason for Recall
Incorrect dose after editing beam number an wedge angle.
Distribution
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
Lot / Code Info
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
Root Cause
Other
Action Taken
Elekta sent Important Field Safety Notice 382-01-MON-009 to all affected customers on 1/10/2017. The notice informs users of the specific product and version numbers by the issue, and any work arounds that can be used to avoid the issue. The notice informs customers that Elekta Regional Support Staff will contact them directly. The notice also included an acknowledgment form to be returned.