Recall Z-1009-2017 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | Dec 21, 2016 |
| Status | Terminated |
| Reason | Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. |
| Root cause | Nonconforming Material/Component |
| Action | Elekta sent an Urgent Important Field Safety Notification letter dated December 2016 to customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice included a reply form to be returned to Elekta. |
| Quantity | 279 |
| Distribution | Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey |
| FDA record | Open on fda.gov |