Terminated

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

FDA Recall Z-0668-2017 · Posted None

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeMUJ

Date Initiated2016-11-17

Date Terminated2021-12-17

Product Quantity2148

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

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.

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.