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Terminated

Monaco Radiation Treatment Planning (RTP) System

FDA Recall Z-0965-2019 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2019-02-08
Date Terminated2024-08-19
Product Quantity14 devices

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183037Monaco RTP SystemElekta, Inc. · 2018-12-04

Official Source

View FDA Recall →

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

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