Devices

Device Recall VERO Linear Accelerator System

Model / Serial
Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the states of NY, FL, TX and OH.
Product Description
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Manufacturer
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
1 Event
- Recall of Device Recall VERO Linear Accelerator System

Manufacturer

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Manufacturer Address
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
Manufacturer Parent Company (2017)
Mitsubishi Heavy Industries Ltd.
Source
USFDA

One device with a similar name

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Device Recall VERO Linear Accelerator System

Model / Serial
Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of NY, FL, and TX.
Product Description
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Manufacturer
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

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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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