Recall Z-1741-2024— RAYSEARCH LABORATORIES AB
Class II · Ongoing
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2024-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: RayStation 7.0.0.19. 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
Product description
RayStation 7.0.0.19. 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.