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Terminated

Monaco 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.

FDA Recall Z-1237-2015 · Posted 2015-03-02

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-12-19
Date Terminated2017-11-17
Product Quantity1354

Reason for Recall

Incorrect CT to ED when using the Monaco Image Statistics Tool.

Firm Action

Elekta 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

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132971MONACOImpac Medical Systems, Inc. · 2013-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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