Recall – RTP System incorrectly displays shift directions

Company: Elekta, Inc.
Date of Enforcement Report: 9/4/2019
Class II

PRODUCT

Monaco Radiation Treatment Planning System (RTP) System

  • Recall Number: Z-2409-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Elekta, Inc. on 8/23/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

49 units

DISTRIBUTION

US Nationwide and International

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.