RAYSEARCH LABORATORIES AB Recall 87868
Description: RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
RAYSEARCH LABORATORIES AB Recall 87868 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1598-2021 |
| Event ID | 87868 |
| Event Description | RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs |
| Product Type | Devices |
| Distribution | Domestic: TN |
| Recall Reason | 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. |
| Device Classification | 20210526 |
| Device Code Info | 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 |
| Center Classification Date | 20210514 |
| Recall Initiation Date | 20210407 |
| Recalling Firm | RAYSEARCH LABORATORIES AB |
| Initial Notification | |
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