Recall Z-0670-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Monaco Radiation Treatment Planning System (RTP) System
| Date | Nov 22, 2019 |
| Status | Open, Classified |
| Reason | Monaco is using the incorrect energy when optimizing and calculating dose. |
| Root cause | Software Design Change |
| Action | An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions. |
| Quantity | 76 (7 US, 69 OUS) |
| Distribution | IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |