Recall Z-0181-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | Oct 30, 2015 (initiated Oct 16, 2015) |
| Status | Terminated |
| Reason | Unintended update of Dose and MU and Incorrect Assignment of Bolus. |
| Root cause | Other |
| Action | Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015. |
| Quantity | 154 |
| Distribution | CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |