RayCare recall
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and…
Why was RayCare 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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"
- Product
- RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- N/A
- Distribution
- US Nationwide distribution including in the state of Tennessee.
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)