FDAFDA · Food and drugs·Recall number Z-1009-2017
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Published January 18, 2017 · Recall initiated: December 21, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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
- Software Versions 5.00 and higher
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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