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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 7 of 7 Results
510(K) Number: K122450
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MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is inte... 2 05/01/2018 Hitachi Ltd., Medical System Operations Group
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 L... 2 03/31/2016 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation ther... 2 03/24/2016 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) 2 05/01/2015 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version... 2 12/17/2014 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. ... 2 09/16/2014 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary an... 2 08/08/2013 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
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