ONCOLOGY DATA SYSTEMS, INC.

MUCheck®

FDA UDI

Oncology Data Systems Inc·00860175002403·MUCheck® Independent Dose Calculation Software....

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 treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

FDA Enforcement

Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·August 15, 2012

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 treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

FDA Recall

Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·July 2, 2012

Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology departments clinical and business information.

FDA Recall

Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·December 16, 2011

The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

FDA Enforcement

Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 8, 2014

ION

FDA Adverse Event

Death ·INTUITIVE SURGICAL, INC·Product code EOQ·October 31, 2023

Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

FDA Recall

Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 14, 2016

Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA

FDA Recall

Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·September 10, 2009

DAVINCI XI

FDA Adverse Event

Injury ·INTUITIVE SURGICAL, INC·Product code NAY·September 17, 2022

ION

FDA Adverse Event

Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·February 15, 2024

DAVINCI XI

FDA Adverse Event

Death ·INTUITIVE SURGICAL, INC·Product code NAY·September 16, 2022

LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.

FDA Recall

Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 21, 2009

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event

Injury ·BECKMAN COULTER, INC.·Product code LTJ·March 13, 2012

ION

FDA Adverse Event

Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·September 26, 2023

ION

FDA Adverse Event

Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·August 9, 2025

ION

FDA Adverse Event

Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·January 14, 2026

Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet.

FDA Recall

Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·June 22, 2011

ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.

FDA Recall

Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 17, 2011

UNKNOWN BD SYRINGE

FDA Adverse Event

Malfunction ·BECTON DICKINSON·Product code FMF·May 20, 2024

DAVINCI XI

FDA Adverse Event

Death ·INTUITIVE SURGICAL, INC·Product code NAY·June 3, 2022