Recall Z-1879-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | May 18, 2016 |
| Status | Terminated |
| Reason | When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. |
| Root cause | Software design |
| Action | Field Safety Notice 382-01-MON-004 was sent to customers on May 18, 2016. The notice informs users of the specific product and version numbers affected by both issues, and any work around that can be used to avoid the issue. The customers were instructed to complete and return the Field Safety Notice Acknowledgement form to their local Elekta as soon as possible. |
| Quantity | 1401 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |