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MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI- recall (Z-1308-2016)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2016-03-31
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radia recall (Z-1244-2016)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2016-03-24
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) recall (Z-1574-2015)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2015-05-01
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Softwa recall (Z-0821-2015)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2014-12-17
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accel recall (Z-2653-2014)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2014-09-16
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Propr recall (Z-1931-2013)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2013-08-08

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Every clearance here is in the API, with alerts when new ones post.