Z-2554-2018 Class II Terminated
FDA device recall Z-2554-2018 was initiated by RAYSEARCH LABORATORIES AB on Jun 6, 2018 and is designated Class II. Reason for recall: The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large… The recall status is terminated (terminated Apr 4, 2019). Affected quantity: 718.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- Jun 6, 2018
- Termination Date
- Apr 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 718
Product Description
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 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
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
Distribution Pattern
US Nationwide distribution.
Code Information
2.5.1.89 , 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 4.0.2.9 , 4.0.3.4 , 4.3.0.14 , 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 , 5.0.2.35, 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 .
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2554-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026