Recall Z-1403-2022— RAYSEARCH LABORATORIES AB
Class II · Terminated
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2022-06-01, terminated 2023-10-04. It names one FDA 510(k) clearance: K200569. Product: RayStation 9B SP1. For radiation treatment planning.. Reason: An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-06-01
- Terminated
- 2023-10-04
- 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 9B SP1. For radiation treatment planning.
Reason for recall
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
Data sourced from openFDA. This site is unofficial and independent of the FDA.