—#170846

Product

Monaco Radiation Treatment Planning (RTP) System

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183037
Affected lot / code info: Software version 5.40

Why it was recalled

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

Root cause (FDA determination)

Software design

Action the firm took

Elekta notified customers on about 2/08/2019 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION." Instructions included to ensure the optimization model is set to "Reproduce Goal Dose" when creating a completion plan. Customers were also requested to post the recall notice in an accessible place for all users to see, advise the appropriate personnel working with the device of the recall, and to complete and return the Acknowledgement Form. The issue will be resolved in Monaco release 5.40.01.

Recalling firm

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

Distribution

Distribution pattern: Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

Timeline

Recall initiated: 2019-02-08
Terminated: 2024-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170846. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.