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RAYSEARCH LABORATORIES AB recalls RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical i
Recalled September 2, 2020 · FDA recall Z-2899-2020 · RAYSEARCH LABORATORIES AB
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. · FDA Class II
Units
N/A
Sold at
US Nationwide distribution including in the state of Tennessee.
Description
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.
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.
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →