Recall Z-1749-2024— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1749-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-28

Class II · Ongoing

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2024-03-28. It names one FDA 510(k) clearance: K220141. Product: RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. 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 record

K220141 — RayStation 11BRaySearch Laboratories AB (PUBL)·cleared 2022-04-15

K-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 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. 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.