FDAJuly 29, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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