—#175901

Product

Monaco Radiation Treatment Planning System (RTP) System

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K190178
Affected lot / code info: Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2019-08-23
Terminated: 2024-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.