Recall Z-1481-2014— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1481-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2014-02-14, terminated 2017-02-15. It names 3 FDA 510(k) clearances: K130617, K120387, K100552. Product: RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.. Reason: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Terminated: 2017-02-15
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

3 on FDA's record

K130617 — RAYSTATIONRaysearch Laboratories AB·cleared 2013-05-10
K120387 — RAYSTATIONRaysearch Laboratories AB·cleared 2012-04-06
K100552 — RAYSTATION VERSION 1.0Raysearch Laboratories AB·cleared 2010-03-12

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 Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.

Reason for recall

RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.

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