—#151096

Product

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K132971
Affected lot / code info: Software Builds 5.00 and higher

Why it was recalled

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

Root cause (FDA determination)

Software design

Action the firm took

Elekta sent an Important Field Safety Notice 382-01-MON-007 was sent to all affected customers on November 17, 2016, to all affected customers. The notice informs users of the specific product version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The notice included a reply form which is to be returned.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-11-17
Terminated: 2021-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.