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All Recalls

Every Raysearch Laboratories Ab Recall

Sorted by most recent. Click any recall for full details.

72 recalls
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer trea...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
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 U...
Medical Devices·1,389 affected·Mar 4, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
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 ...
Medical Devices·956 affected·Nov 18, 2019
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Medical Devices·69 affected·Nov 12, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Medical Devices·110 affected·Sep 21, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, Ray...
Medical Devices·746 affected·Jun 29, 2018
High RiskFDA
Raysearch Laboratories Ab
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, ...
Medical Devices·2,484 affected·Jan 26, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (Ray...
Medical Devices·744 affected·Nov 20, 2017
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and ana...
Medical Devices·741 affected·Jan 18, 2017
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed...
Medical Devices·66 affected·Nov 9, 2016
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analy...
Medical Devices·540 affected·Oct 11, 2016
High RiskFDA
Raysearch Laboratories Ab
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RaySta...
Medical Devices·245 affected·Mar 4, 2015
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Medical Devices·251 affected·Feb 14, 2014
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Medical Devices·19 affected·Feb 6, 2014
High RiskFDA
Raysearch Laboratories Ab
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Medical Devices·195 affected·Oct 23, 2013
High RiskFDA
Raysearch Laboratories Ab
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy T...
Medical Devices·70 affected·Feb 15, 2013
High RiskFDA
Raysearch Laboratories Ab
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Produ...
Medical Devices·19 affected·May 9, 2012
High RiskFDA
Raysearch Laboratories Ab
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial na...
Medical Devices·20 affected·Oct 10, 2011
High RiskFDA
Raysearch Laboratories Ab
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using i...
Medical Devices·15 affected·May 30, 2011