Monaco RTP System Product Usage: The Monaco system is recall
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation…
Why was Monaco RTP System Product Usage: The Monaco system is recalled?
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
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?
Monaco versions 5.10.00 and higher
- Product
- Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation…
- Recalling firm
- Elekta, Inc.
- Quantity
- 1401 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe
- Recall date
- June 8, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)