Recall Z-0294-2019— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-0294-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-21

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2018-09-21, terminated 2020-06-16. It names one FDA 510(k) clearance: K180379. Product: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.. Reason: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2018-09-21
Terminated: 2020-06-16
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K180379 — RayStation 7RaySearch Laboratories AB (PUBL)·cleared 2018-04-25

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 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

Reason for recall

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

Data sourced from openFDA. This site is unofficial and independent of the FDA.