Monaco RTP System Product Usage: Used to make treatment recall
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Why was Monaco RTP System Product Usage: Used to make treatment recalled?
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions 5.00 and higher
- Product
- Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Recalling firm
- Elekta, Inc.
- 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
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)