Monaco TRP System The Monaco system is used to make recall
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Why was Monaco TRP System The Monaco system is used to make recalled?
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
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 Builds 5.00 and higher
- Product
- Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Recalling firm
- Elekta, Inc.
- Quantity
- 2148
- Distribution
- Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Unite Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)