02

Dec

2020

Recall – Treatment Planning System reference linked to wrong ROI

recall, softwareerror

0

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 12/2/2020
Class II

PRODUCT

RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 – Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

Recall Number: Z-0478-2021

REASON

If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 10/8/2020. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2768

DISTRIBUTION

U.S. Nationwide

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