Recall Z-2581-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
| Date | Sep 4, 2014 (initiated Aug 18, 2014) |
| Status | Terminated |
| Reason | Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan. |
| Root cause | Software design |
| Action | The firm, Elekta, issued an "URGENT IMPORTANT FIELD SAFETY NOTICE (IFSN 382-01-MON-001)" to all affected customers on August 18, 2014. The notice describes the product, problems and actions taken. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in patches to the following releases - Monaco 3.30 and Monaco 5.00. Development is underway with a release date of September 2014 with confirmation of installation of the patch no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers |
| Quantity | 928 units |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, FL, IL, IN, MD, MA, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, Puerto Rico; and countries of: Algeria, Angola, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Belgium, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132971 | MONACO Impac Medical Systems, Inc., Nov 20, 2013 |