The Recall Desk

Manufacturer

Varian Medical Systems, Inc.

21 recalls in our database name Varian Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
1
Most recent
2020-05-13

Of the 21 recalls from Varian Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • HighFDA (Devices)·Z-1899-2020·2020-05-13

    Varian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure

    Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.

    Product
    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2019·2019-01-30

    Varian Eclipse Treatment Planning System Proton Algorithm Recall

    Varian Medical Systems is recalling the Eclipse Treatment Planning System due to a software error in the Proton Convolution Superposition algorithm that miscalculates dose ranges for non-square CT images.

    Product
    Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2017·2017-01-18

    Varian Eclipse Treatment Planning System Software Recall for Contouring Errors

    Varian Medical Systems is recalling 42 Eclipse Treatment Planning System devices due to a software defect that prevents contours from saving consistently.

    Product
    Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign d
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0077-2017·2016-10-19

    Varian Head Frame Posts Recalled Due to Rotation Risk

    Varian Medical Systems is recalling 75 Head Frame Posts because they can rotate easily on the mounting cam. No serious injuries have been reported.

    Product
    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilizatio
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2150-2016·2016-07-20

    Varian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors

    Varian Medical Systems is recalling AlignRT Plus systems because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2016·2016-07-20

    Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes

    Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automaticall
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0805-2016·2016-02-24

    Varian Eclipse Treatment Planning System Recall for Dose Calculation Error

    Varian Medical Systems is recalling Eclipse Treatment Planning System versions 11, 13.0, 13.5, and 13.6 due to a dose calculation error that may result in unintended radiation exposure.

    Product
    Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan exter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2015·2015-07-08

    Varian VariSource iX Afterloader Systems Recalled for Calculation Errors

    Varian Medical Systems is recalling 55 VariSource iX afterloader systems because a software freeze can cause incorrect radiation dose calculations.

    Product
    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherap
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1829-2015·2015-07-01

    Varian Leipzig-style Brachytherapy Applicator Set Recalled for Dose Rate Discrepancy

    Varian Medical Systems is recalling 46 Leipzig-style Surface Applicator Sets because the actual dose rate is approximately 14% higher than the rate published in the Instructions for Use.

    Product
    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0526-2015·2014-12-24

    Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire

    Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.

    Product
    Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2654-2014·2014-09-24

    Varian 4D Integrated Treatment Console Recall for Safety Interlock Defect

    Varian Medical Systems is recalling 512 4D Integrated Treatment Consoles because user error can allow improper clearing of safety interlocks.

    Product
    4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2567-2014·2014-09-24

    Varian C-Series Linear Accelerators Recalled for Beam Output Decrease

    Varian Medical Systems is recalling C-Series High Energy Linear Accelerators due to a trend of unexpected decreases in beam output during 6MV photon treatment.

    Product
    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1502-2014·2014-04-30

    Varian On-Board Imager Elbow Motor Shaft Recall

    Varian Medical Systems is recalling On-Board Imager devices with Type 01 elbow motors due to a shaft failure caused by belt over-tensioning.

    Product
    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in rela
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0552-2014·2014-01-01

    Varian Eclipse Treatment Planning System Software Deficiency Recall

    Varian Medical Systems is recalling Eclipse Treatment Planning System software due to a defect that may cause Monitor units to change unexpectedly during dose parameter adjustments.

    Product
    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0439-2014·2013-12-11

    Varian Medical Systems Recalls C-Series Linear Accelerators for Software Correction

    Varian Medical Systems is recalling 3,809 C-Series linear accelerators to install a software solution that corrects a previous issue.

    Product
    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2014·2013-10-30

    Varian Medical Recalls Breast Template System Due to Sterilization Defect

    Varian Medical Systems is recalling 3 sets of the VARISOURCE Breast Template System because the templates may bend and turn opaque after steam sterilization.

    Product
    VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2013·2013-05-22

    Varian Segmented Cylinder Applicator Set Recalled for Potential Slippage During Treatment

    Varian Medical Systems is recalling 21 Segmented Cylinder Applicator Sets used for brachytherapy because they may slip during treatment, causing radiation to be delivered to areas outside the target.

    Product
    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2013·2013-02-06

    Varian Medical Systems Recalls Titanium Rectal Retractors for Brachytherapy

    Varian Medical Systems is recalling 152 titanium rectal retractors used in brachytherapy due to potential contamination risks that could cause infections, toxicity, or allergic reactions.

    Product
    Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2013·2013-02-06

    Varian Medical Rectal Retractors Recalled for Contamination Risk

    Varian Medical Systems is recalling stainless steel rectal retractors used in brachytherapy due to potential contamination that could cause infections, toxicity, or allergic reactions.

    Product
    Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2013·2012-12-26

    Varian Segmented Cervix Applicator Set Recalled for Difficult Disconnection

    Varian Medical Systems is recalling 15 units of the Segmented Cervix Applicator Set because the guide tube is difficult to disconnect from the cervical sleeve.

    Product
    Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, v
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Varian Medical Systems

American healthcare company

Country
United States
Founded
1948

Official website

Source: Wikidata (Q4993917), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.