—#174511

Product

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

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K151233
Affected lot / code info: all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Elekta Inc
Address: 13723 Riverport Dr, Ste 100, Maryland Heights, Missouri 63043-4819

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2019-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174511. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.