PlainRecalls

RAYSEARCH LABORATORIES AB

77 recalls on record · Latest: Jan 28, 2026

FDA Devices Moderate Jun 17, 2020

RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

FDA Devices Moderate Apr 1, 2020

RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RaySta…

FDA Devices Moderate Mar 18, 2020

RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system

FDA Devices Moderate Mar 18, 2020

RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system

FDA Devices Moderate Mar 18, 2020

RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system

FDA Devices Moderate Mar 18, 2020

RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system

FDA Devices Moderate Mar 18, 2020

RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system

FDA Devices Moderate Jan 1, 2020

RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Us…

FDA Devices Moderate Jul 10, 2019

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) .…

FDA Devices Moderate Jan 2, 2019

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A

FDA Devices Moderate Nov 7, 2018

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

FDA Devices Moderate Jul 25, 2018

RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (R…

FDA Devices Moderate Apr 4, 2018

Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.…

FDA Devices Moderate Jan 24, 2018

RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide tr…

FDA Devices Moderate Apr 19, 2017

Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of rad…

FDA Devices Moderate Dec 14, 2016

RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatme…

FDA Devices Moderate Dec 14, 2016

Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radia…

FDA Devices Moderate Sep 23, 2015

Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation the…

FDA Devices Moderate Apr 1, 2015

RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, th…

FDA Devices Moderate Jun 25, 2014

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

FDA Devices Moderate Apr 30, 2014

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

FDA Devices Moderate Apr 9, 2014

RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software

FDA Devices Moderate Nov 20, 2013

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

FDA Devices Moderate Jun 5, 2013

RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. …

FDA Devices Moderate Oct 3, 2012

SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTher…

FDA Devices Moderate Sep 26, 2012

The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, …

FDA Devices Moderate Sep 12, 2012

Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime …