Home / Recalls / Medical Devices
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK recalls MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Recalled May 13, 2015 · FDA recall Z-1574-2015 · 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. · FDA Class II
Units
11 units total
Sold at
Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Description
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.
Product
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Manufacturer(s)
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →