Recall Z-1679-2015— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1679-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-08

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2015-05-08, terminated 2017-04-11. It names 3 FDA 510(k) clearances: K140187, K130617, K120387. Product: RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.. Reason: RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Terminated: 2017-04-11
Firm location: Stockholm, Sweden

510(k) clearances named in this recall

3 on FDA's record

K140187 — RAY STATIONRaysearch Laboratories AB·cleared 2014-05-15
K130617 — RAYSTATIONRaysearch Laboratories AB·cleared 2013-05-10
K120387 — RAYSTATIONRaysearch Laboratories AB·cleared 2012-04-06

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

RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Reason for recall

RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.

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