Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
This recall has been terminated (originally issued December 21, 2016).
- Company
- Elekta, Inc.
- Recall Initiated
- December 21, 2016
- Terminated
- July 16, 2021
- Recall Number
- Z-1009-2017
- Quantity
- 279
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
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
Lot / Code Info
Software Versions 5.00 and higher
Root Cause
Nonconforming Material/Component
Action Taken
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.