Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reported: January 18, 2017 Initiated: December 21, 2016 #Z-1009-2017
Product Description
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 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
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Recalled by Elekta, Inc.. Units affected: 279.
Why was this product recalled? ▼
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-1009-2017.
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