Z-1598-2021 Class II Terminated
FDA device recall Z-1598-2021 was initiated by RAYSEARCH LABORATORIES AB on April 7, 2021 and is designated Class II. Reason for recall: When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment … The recall status is terminated (terminated June 2, 2023). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- April 7, 2021
- Termination Date
- June 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Reason for Recall
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
Distribution Pattern
Domestic: TN
Code Information
Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613