FDA-Device2015-05-13Class II
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Hazard
The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
Sold states
Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Affected count
11 units total
Manufactured in
6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA, N/A, Japan
Products
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1574-2015Don't want to check this manually?
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