Recall Z-1419-2013— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1419-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-15

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2013-02-15, terminated 2017-02-17. It names one FDA 510(k) clearance: K120387. Product: RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.. Reason: Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2013-02-15
Terminated: 2017-02-17
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

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

RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Reason for recall

Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

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