Recall – Radiation treatment planning system scales incorrectly under certain conditions

Company: Elekta Inc
Date of Enforcement Report: 8/7/2019
Class II

PRODUCT

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

Recall Number: Z-2091-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Elekta Inc on 7/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1396 units

DISTRIBUTION

Worldwide

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

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