Recall Z-1598-2021— RAYSEARCH LABORATORIES AB
Class II · Terminated
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2021-04-07, terminated 2023-06-02. It names one FDA 510(k) clearance: K200569. Product: RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs. 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..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-07
- Terminated
- 2023-06-02
- Firm location
- Stockholm, N/A, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.