Manufacturer

Varian Medical Systems, Inc. Oncology Systems

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

What the numbers show

Total: 9
Critical: 0
Severe: 1
Most recent: 2013-05-22

Of the 9 recalls from Varian Medical Systems, Inc. Oncology Systems we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (11%) 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.

1–9 of 9

HighFDA (Devices)·Z-1325-2013·2013-05-22
Varian High Energy Clinacs Radiation Treatment System Recall for Beam Symmetry
Varian is recalling High Energy Clinacs because photon beams may develop asymmetry, potentially causing minor patient injury or decreased disease control.
Product
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1163-2013·2013-05-01
Varian RPM Respiratory Gating System Recall for Waveform Anomaly
Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.
Product
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0867-2013·2013-02-27
Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian Medical Systems is recalling 1,168 units of the Eclipse Treatment Planning System because the Pencil Beam Convolution 11.0 algorithm incorrectly calculates dose for dynamic plans with different energy fields.
Product
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0531-2013·2012-12-26
Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly
Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.
Product
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured an
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0187-2013·2012-11-07
Varian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error
Varian Medical Systems is recalling ARIA Radiation Oncology Version 11 software because monitor units may be incorrect when continuing partial treatment.
Product
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2462-2012·2012-10-03
Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian is recalling Eclipse Treatment Planning Systems because a clock synchronization issue can cause incorrect dose calculations, potentially leading to under- or over-dosing of patients.
Product
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2383-2012·2012-09-26
Varian Linear Accelerators Recalled Due to X-Jaw Carrier Alloy Defect
Varian Medical Systems is recalling 221 linear accelerators worldwide because incorrect metal alloy in X-jaw carriers may cause cracking and undetected under-dosing.
Product
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indic
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2153-2012·2012-08-15
Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import
Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.
Product
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2012·2012-07-25
Varian Eclipse Treatment Planning System Recall for Radiotherapy Prescription Errors
Varian is recalling Eclipse Treatment Planning Systems because changing dose prescriptions in certain plans may result in incorrect Monitor Units and dose distributions.
Product
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for pa
Category
Medical Device
Distribution
Distributed nationwide