Recall – Manual steps for import of treatment records not clear

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 7/1/2020
Class II

PRODUCT

RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

Recall Number: Z-2426-2020

REASON

It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 5/26/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

12

DISTRIBUTION

U.S. Nationwide and International

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