Recall Z-1825-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
| Date | Apr 16, 2020 |
| Status | Open, Classified |
| Reason | The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose. |
| Root cause | Software design |
| Action | In April of 2020, Elekta Inc. prepared an Urgent/Important Field Safety Notice identifying this issue, the actions that should be taken by the user/customer in order to prevent risks for patients and/or users, and the actions planned by Elekta to correct the problem. PRODUCT: The Monaco RTP System with versions 5.40 or 5.40.01 installed in or after June of 2018. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Customers/users are instructed to follow their standard clinical practice of reviewing plans, including the review of contours and volumes. DVHs that show unexpected overdose or under-dose |
| Quantity | 96 devices |
| Distribution | Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183037 | Monaco RTP System Elekta, Inc., Dec 4, 2018 |