Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reported: December 7, 2016 Initiated: November 17, 2016 #Z-0668-2017
Product Description
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Recalled by Elekta, Inc.. Units affected: 2148.
Why was this product recalled? ▼
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0668-2017.
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