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Open, Classified

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

FDA Recall Z-2091-2019 · Posted None

Recalling FirmElekta Inc
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2019-07-03
Product Quantity1396 units

Reason for Recall

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

Firm Action

Elekta began distribution of their Important Field Safety Notice to all affected customers from 07/03/2019 by email. The notice informs users of the specific product and version numbers affected by the issue, and any work-arounds that can be used to avoid the issue. The problem will be resolved in a future Monaco software release.

Root Cause

Under Investigation by firm

Distribution Pattern

worldwide

Official Source

View FDA Recall →

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

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