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Terminated

Monaco Radiation Treatment Planning System (RTP) System

FDA Recall Z-2409-2019 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2019-08-23
Date Terminated2024-06-28
Product Quantity49 units

Reason for Recall

Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Firm Action

Elekta Inc. notified customers on about 08/23/2019 via "IMPORTANT FIELD SAFETY NOTIFICATION" letter. The letter informed customers that the Monaco is displaying some incorrect shift information on the Scan and Setup Reference Report and is DICOM exporting incorrect shift information. Instructions included that all shifts should be verified before treatment, that a software fix is planned. Customer were also instructed to post the notice in a place accessible to all users, advise personnel working with the device of the issue, and to complete and return the Acknowledgement Form provided.

Root Cause

Device Design

Distribution Pattern

Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190178Monaco RTP SystemElekta, Inc. · 2019-03-29

Official Source

View FDA Recall →

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

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