RayStation stand-alone software treatment planning recall
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6…
Why was RayStation stand-alone software treatment planning recalled?
If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.
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?
Software Versions 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61
- Product
- RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 746
- Distribution
- US Nationwide Distribution to accounts in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)