Recall Z-1299-2022— RAYSEARCH LABORATORIES AB
Class II · Terminated
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2022-06-10, terminated 2024-06-11. It names one FDA 510(k) clearance: K220141. Product: RayStation 11B. Reason: This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-06-10
- Terminated
- 2024-06-11
- Firm location
- Stockholm, 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 11B
Reason for recall
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
Data sourced from openFDA. This site is unofficial and independent of the FDA.