Reported Sep 2, 2020 · Ongoing
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical…
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Sveavagen 9 · Stockholm, N/A · N/A
Is this the product you have?
- RayCare, device
- is stand-alone software - Product Usageused to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care
- Lot codes and dates
Model #: 2C SP22C SP33A SP13B
- and 4A Software Version
2.2.2.307822.2.3.534233.0.1.435973.1.0.603414.0.0.60621"
- Amount recalled
- N/A
Where it was sold
- Nationwide
- TN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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