Recall Z-0668-2017 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | Nov 17, 2016 |
| Status | Terminated |
| Reason | Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice 382-01-MON-007 was sent to all affected customers on November 17, 2016, to all affected customers. The notice informs users of the specific product version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The notice included a reply form which is to be returned. |
| Quantity | 2148 |
| Distribution | Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bul |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132971 | MONACO Impac Medical Systems, Inc., Nov 20, 2013 |