RayStation 11B recall
RayStation 11B
Why was RayStation 11B recalled?
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68
- Product
- RayStation 11B
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 26
- Distribution
- US Nationwide distribution in the states of NJ and TX.
- Recall date
- July 6, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)