Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 9/2/2020
Class II

PRODUCT

RayCare, device is stand-alone software – Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

Recall Number: Z-2899-2020

REASON

When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 7/29/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

NA

DISTRIBUTION

U.S. Nationwide