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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco

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 Class 2 Device Recall Monacosee related information
Date Initiated by FirmDecember 19, 2014
Date PostedMarch 02, 2015
Recall Status1 Terminated 3 on November 17, 2017
Recall NumberZ-1237-2015
Recall Event ID 70434
510(K)NumberK132971 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductMonaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Code Information Monaco Release 3.30 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
770-300-9725
Manufacturer Reason
for Recall		Incorrect CT to ED when using the Monaco Image Statistics Tool.
FDA Determined
Cause 2		Other
ActionElekta sent an Important User Notice on December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice provided a workaround until new software releases. The notice included a acknowledgement form to be returned. For further questions please call (770) 300-9725
Quantity in Commerce1354
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUJ
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