RayStation/RayPlan 8B recall
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Why was RayStation/RayPlan 8B recalled?
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
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 07350002010129
- Product
- RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 1 system in the U.S.
- Distribution
- The products were distributed to the following US states: TN
- Recall date
- March 18, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)