Recall Z-0281-2014— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-0281-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-23

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2013-10-23, terminated 2017-02-17. It names 2 FDA 510(k) clearances: K130617, K120387. Product: Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0. Reason: Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Terminated: 2017-02-17
Firm location: Stockholm, Sweden

510(k) clearances named in this recall

2 on FDA's record

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

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Reason for recall

Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

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