Z-2497-2018 Class II Terminated
FDA device recall Z-2497-2018 was initiated by RAYSEARCH LABORATORIES AB on Jun 29, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jul 16, 2020). Affected quantity: 746.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 25, 2018
- Initiation Date
- Jun 29, 2018
- Termination Date
- Jul 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 746
Product Description
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2497-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026