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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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