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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: K080701
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FDA Recall
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0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take ge... 2 11/08/2012 FEI # 1000125362
Shimadzu Medical Systems
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to tak... 2 06/03/2013 FEI # 1000125362
Shimadzu Medical Systems
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and ... 2 12/18/2015 FEI # 1000125362
Shimadzu Medical Systems
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to ... 2 03/21/2019 FEI # 1000513161
Fujifilm Medical Systems U.S.A., Inc.
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is i... 2 03/21/2019 FEI # 1000125362
Shimadzu Medical Systems Usa Com
Fujifilm FDR Go Plus mobile X-ray system 2 08/30/2019 FEI # 1000513161
Fujifilm Medical Systems U.S.A., Inc.
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Mad... 2 12/04/2020 FEI # 1000125362
Shimadzu Medical Systems
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