Recall Z-1233-2023 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 | Mar 8, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. |
| Root cause | Software design |
| Action | Elekta notified consignees of the issue on 02/28/2023 via email. Consignees were instructed to contact Elekta Care Support if assistance is needed to identify affected patients, post the recall information in a place accessible to all users until the action is complete, and complete and return the Important Field Safety Notice Acknowledgement form. Additionally, the issue is corrected in Monaco releases 5.40 and above. If you are running a 5.11.xx version, please contact Elekta Care Support to upgrade to a newer software version. |
| Quantity | 2,020 units |
| Distribution | Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |