Recall – Radiation treatment planning system potential for inaccurate dose

Company: Elekta Inc
Date of Enforcement Report: 5/7/2020
Class II

PRODUCT

Elekta MONACO RTP Sytem, radiation treatment planning software system – Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Recall Number: Z-1803-2020

REASON

The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.

RECALLING FIRM/MANUFACTURER

Elekta Inc on 4/16/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

96 devices

DISTRIBUTION

U.S. Nationwide and International

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.