Terminated

Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

FDA Recall Z-1044-2017 · Posted None

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeMUJ

Date Initiated2017-01-10

Date Terminated2020-08-18

Product Quantity1999

Reason for Recall

Incorrect dose after editing beam number an wedge angle.

Firm Action

Elekta sent Important Field Safety Notice 382-01-MON-009 to all affected customers on 1/10/2017. The notice informs users of the specific product and version numbers by the issue, and any work arounds that can be used to avoid the issue. The notice informs customers that Elekta Regional Support Staff will contact them directly. The notice also included an acknowledgment form to be returned.

Root Cause

Other

Distribution Pattern

AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe

Official Source

View FDA Recall →

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