Recall Z-2409-2019 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco Radiation Treatment Planning System (RTP) System
| Date | Aug 23, 2019 |
| Status | Terminated |
| Reason | Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. |
| Root cause | Device Design |
| Action | Elekta Inc. notified customers on about 08/23/2019 via "IMPORTANT FIELD SAFETY NOTIFICATION" letter. The letter informed customers that the Monaco is displaying some incorrect shift information on the Scan and Setup Reference Report and is DICOM exporting incorrect shift information. Instructions included that all shifts should be verified before treatment, that a software fix is planned. Customer were also instructed to post the notice in a place accessible to all users, advise personnel working with the device of the issue, and to complete and return the Acknowledgement Form provided. |
| Quantity | 49 units |
| Distribution | Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190178 | Monaco RTP System Elekta, Inc., Mar 29, 2019 |