International Medical Devices Database

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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Type of Event
Safety alert
Date
2012-03-07
Event Country
Hong Kong
Event Source
DH
Event Source URL
https://www.mdco.gov.hk/english/safety/recalls/recalls_20120307a.html
Notes / Alerts

Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data

Medical Device Safety Alert
Reason
Field safety notice: 4d integrated treatment console and truebeam medical device manufacturer, varian medical systems, has issued a field safety notice concerning 4d integrated treatment console (4ditc) and truebeam. varian has identified potential discrepancies in intensity modulated radiotherapy (imrt) complete irradiated area outline (ciao) outline visualization between treatment applications (4d integrated treatment console (4ditc), am editor, on-board imager, portalvision and truebeam), and treatment planning & oncology information system applications (eclipse, aria, rtchart, off-line image review). according to varian, the discrepancy is a display issue that is sometimes seen when an ad-hoc image template has been added, after the plan has been loaded on the 4ditc. none of the reported discrepancies affect the delivered dose to the imrt field, and the planned mlc and the actual mlc used for treatment are correct. p> according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console and TrueBeam

Model / Serial
Product Description
Medical Device Safety Alert: 4D Integrated Treatment Console and TrueBeam
Manufacturer
Varian Medical Systems

Manufacturer

Varian Medical Systems

Manufacturer Parent Company (2017)
Varian Medical Systems Inc
Source
DH

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Safety Alert for 4D Integrated Treatment Console and TrueBeam

What is this?

Device

4D Integrated Treatment Console and TrueBeam

Manufacturer

Varian Medical Systems