medical Class II Updated 2020-09-02

RAYSEARCH LABORATORIES AB recalls RayCare, device is stand-alone software - Product Usage: use

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"
View official government recall

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