Monaco radiation therapy treatment planning system. The recall
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external…
Why was Monaco radiation therapy treatment planning system. The recalled?
Incorrect CT to ED when using the Monaco Image Statistics Tool.
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 Release 3.30 and higher
- Product
- Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external…
- Recalling firm
- Elekta, Inc.
- Quantity
- 1354
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Algeria, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Kazakhstan, Sri Lanka, Lithuania, Libya, Morocco, Myanmar, Malta, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, Venezuela and South Africa.
- Recall date
- March 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)