Elekta, Inc.: Monaco Radiation Treatment Planning System (RTP) System

Is my product affected?

Monaco Radiation Treatment Planning System (RTP) System

• UPC 00858164002244
• UPC 00858164002268

Check against the official notice below — it lists the full affected range.

What happened

Elekta, Inc. is recalling the Monaco Radiation Treatment Planning System (RTP) due to a software issue where the system displays incorrect directional information for anatomy and beam shifts on scan and setup reference reports, and exports this same incorrect directional data in DICOM format. The affected software versions are Build 5.50.00 and 5.51.00, with 49 units distributed in the United States (Ohio and Indiana) and internationally (Germany, Greece, and Sweden).

The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden. Quantity: 49 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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