Recall Z-1044-2017 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 | Jan 10, 2017 |
| Status | Terminated |
| Reason | Incorrect dose after editing beam number an wedge angle. |
| Root cause | Other |
| Action | Elekta sent Important Field Safety Notice 382-01-MON-009 to all affected customers on 1/10/2017. The notice informs users of the specific product and version numbers by the issue, and any work arounds that can be used to avoid the issue. The notice informs customers that Elekta Regional Support Staff will contact them directly. The notice also included an acknowledgment form to be returned. |
| Quantity | 1999 |
| Distribution | AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |