Recall Z-1746-2024— RAYSEARCH LABORATORIES AB
Class II · Ongoing
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2024-03-28. It names one FDA 510(k) clearance: K200569. Product: RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.. Reason: Potential for reported SSD to be too high..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-28
- 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 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Reason for recall
Potential for reported SSD to be too high.
Data sourced from openFDA. This site is unofficial and independent of the FDA.