Recall Z-1464-2020— RAYSEARCH LABORATORIES AB
Class II · Terminated
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2020-02-20, terminated 2024-11-05. It names one FDA 510(k) clearance: K190387. Product: RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system. Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-20
- Terminated
- 2024-11-05
- 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/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Reason for recall
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Data sourced from openFDA. This site is unofficial and independent of the FDA.