Recall Z-2712-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | Aug 18, 2016 |
| Status | Terminated |
| Reason | In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner. |
| Root cause | Unknown/Undetermined by firm |
| Action | Important User Notice 382-03-MON-003 was sent to customers on August 18, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The letter also states that the problem will be in a future Monaco release. The customers were instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta as soon as possible but no longer than 30 days from receipt. Questions can be directed to the local Elekta office. |
| Quantity | 3,012 units |
| Distribution | Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc., Jun 24, 2011 |