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Recall Observatory FDA recall evidence

Device 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.

Z-2899-2020

July 29, 2020

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 86249
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2899-2020

Official wording

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.

Code information: 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"

Distribution pattern: US Nationwide distribution including in the state of Tennessee.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.