Recall Z-0112-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | Oct 7, 2015 (initiated Sep 15, 2015) |
| Status | Terminated |
| Reason | Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. |
| Root cause | Device Design |
| Action | The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office. |
| Quantity | 154 units |
| Distribution | Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |