Elekta, Inc.
Norcross, GA
This page shows every FDA and USDA recall linked to Elekta, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
46
Total Recalls
2005
First Recall
2012
Most Recent
MOSAIQ
MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow managemen...
Oct 30, 2012
· Device
Terminated
Oncentra External Beam 4.1.
Radiation treatment planning software designed to analyze and plan radiation trea...
Oct 23, 2012
· Device
Terminated
Precise Digital Accelerator
Delivery of radiation to defined target volumes
Sep 19, 2012
· Device
Terminated
Multileaf Collimator
To be used for single or multiple fractions, delivered as static and/or dynamic beams of...
Sep 10, 2012
· Device
Terminated
Focal SIM
Planning of radiation therapy
Jul 12, 2012
· Device
Terminated
Monaco
Product Usage:
Planning of radiation therapy
Jul 12, 2012
· Device
Terminated
MLCi/MCLi2.
Radiation therapy.
May 23, 2012
· Device
Terminated
Elekta Synergy XVI 4.5 and R4.6
To be used as part of radiation therapy treatment process.
Feb 21, 2012
· Device
Terminated
Elekta Synergy XVI R.4.5 and R4.6
ProducT Usage: To be used as part of radiation therapy treatment process.
Dec 1, 2011
· Device
Terminated
Elekta Synergy XVI X-ray Volume Imaging System
To be used as part of radiation therapy treatment process.
Dec 1, 2011
· Device
Terminated
Elekta Leksell Gamma Plan
Product Usage: Gamma Plan is a computer based system designed for Gamma Knife trea...
Nov 30, 2011
· Device
Terminated
Stereotactic Circular Collimator
Product Usage: This device is intended to hold a patient's head in a fixed...
Nov 30, 2011
· Device
Terminated
Elekta Leksell Gamma Knife C 1.2, 4 and 4C
Product Usage: Leksell Gamma Knife is a teletherapy device inten...
Nov 30, 2011
· Device
Terminated
Elekta Synergy XVI 4.5
Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as deter...
Nov 29, 2011
· Device
Terminated
Elekta Synergy
The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant...
Aug 29, 2011
· Device
Terminated
Dynamic Multileaf Collimator (DMLC)
Shapes the radiation beam in treatment therapy.
May 25, 2011
· Device
Terminated
Elekta Synergy XVI R4.5
Radiation therapy treatment of malignant neoplastic diseases, as determined by a lic...
Mar 22, 2011
· Device
Terminated
PrecisePLAN Treatment Planning System
Intended use: To plan multiple beam radiation therapy treatments.
Mar 4, 2011
· Device
Terminated
Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2
A user interface of rthe SL/SLi Series Linear Accelerators that are used...
Mar 4, 2011
· Device
Terminated
PrecisePLAN Treatment Planning System
To plan multiple beam radiation therapy treatments.
Mar 2, 2011
· Device
Terminated
Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined...
Feb 15, 2011
· Device
Terminated
Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray...
Feb 15, 2011
· Device
Terminated
Leksell GammaPlan, Model 5.34.
Intended to be used for planning the dosimetry of treatments in stereotactic r...
Feb 14, 2011
· Device
Terminated
Precise Treatment Table
The Precise Treatment Table is intended as a universal patient treatment support and p...
Feb 3, 2011
· Device
Terminated
Elekta VBH Head FIX
The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stere...
Dec 3, 2010
· Device
Terminated
Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Swede...
Oct 28, 2010
· Device
Terminated
Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined...
Sep 1, 2010
· Device
Terminated
Leksell GammaPlan 8.0 image fusion
Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufac...
May 14, 2010
· Device
Terminated
Leksell Gamma Knife C
Apr 29, 2010
· Device
Terminated
Elekta Synergy
Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
Apr 27, 2010
· Device
Terminated
Leksell GammaPlan.
Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta...
Apr 27, 2010
· Device
Terminated
iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
Apr 26, 2010
· Device
Terminated
Precise Treatment Table
Intended as a universal patient treatment support and positioning table for radiation...
Apr 23, 2010
· Device
Terminated
Leksell SurgiPlan
Apr 22, 2010
· Device
Terminated
Leksell Gamma Knife C
Apr 22, 2010
· Device
Terminated
Elekta Synergy XVI
The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determi...
Apr 22, 2010
· Device
Terminated
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 3...
Apr 16, 2010
· Device
Terminated
PrecisePLAN 2.10 Treatment Planning System
Apr 16, 2010
· Device
Terminated
Leksell Gamma Knife.
Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradi...
Apr 13, 2010
· Device
Terminated
Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.
Indicated...
Apr 5, 2010
· Device
Terminated
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Nor...
Apr 5, 2010
· Device
Terminated
Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. No...
Apr 5, 2010
· Device
Terminated
Elekta SL Series/Precise Digital Accelerator.
The product is used with radiation therapy treatment of maligna...
Mar 18, 2010
· Device
Terminated
Leksell Gamma Knife Perfexion, Article #715000.
Teletherapy device intended for stereotactic irradiation of h...
Mar 17, 2010
· Device
Terminated
PrecisePLAN 2.15 Treatment Planning System.
The product is used to plan multiple beam radiation therapy trea...
Mar 16, 2010
· Device
Terminated
Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
Feb 7, 2007
· Device
Terminated