Z-0294-2019 Class II Terminated
FDA device recall Z-0294-2019 was initiated by RAYSEARCH LABORATORIES AB on Sep 21, 2018 and is designated Class II. Reason for recall: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 110 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- Sep 21, 2018
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
Product Description
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Reason for Recall
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Distribution Pattern
Nationwide
Code Information
Software, include version number: 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 , 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0294-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026