Recall Z-1745-2024— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1745-2024
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: K200569. Product: RayStation 9.1.0.933 and 9.2.0.483. 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

K200569 — RayStationRaySearch Laboratories AB (PUBL)·cleared 2020-09-24

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 9.1.0.933 and 9.2.0.483. 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.