Devices

Device Recall Varian brand Eclipse Treatment Planning System

Model / Serial
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Class II Recall - Worldwide Distribution -- USA (nationwide) including the countries of Canada and Europe.
Product Description
Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; || Reference/FSCA Identifier: CP-07007, 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 patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
1 Event
- Recall of Device Recall Varian brand Eclipse Treatment Planning System

Manufacturer

Varian Medical Systems, Inc. Oncology Systems

Manufacturer Address
Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
Manufacturer Parent Company (2017)
Varian Medical Systems Inc
Source
USFDA

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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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