Devices

Device Recall 4D Intergrated Treatment Console

Model / Serial
Affected Serial Numbers: H510378, H510392, H510712, H510844, H511781, H512506, H512547, H512645, H513143, H513196, H513460, H514034, H514385, H514468, H514759, H514941, H511891
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Class 2 Recall - Worldwide Distribution -- USA including states of ; CA, NV, NJ, GA, IL, and TX and countries of Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland and United Kingdom.
Product Description
The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
1 Event
- Recall of Device Recall 4D Intergrated Treatment Console

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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