Recall Z-0660-2017 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 | Nov 3, 2016 |
| Status | Terminated |
| Reason | Incorrect Dose when using the reset function. |
| Root cause | Software design |
| Action | Important Field Safety Notice 382-01-MON-006 was sent to all affected customers on 11/3/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. An acknowledgement form was included which is to be returned to Elekta. |
| Quantity | 671 |
| Distribution | AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |