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Elekta, Inc. recalls Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radi
Recalled January 18, 2017 · FDA recall Z-1009-2017 · Elekta
Hazard
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. · FDA Class II
Units
279
Sold at
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
Description
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Product
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →