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Devices
Bicor HiP XRay System
Model / Serial
Model number 6379767 - Serial numbers: 2002, 2004, 2005, 2011, 2012, 2015, 2016, 2017, 2018, 2022, 2025, 2026, 2033, 2042, 2045, 2055, 2058, 2059, 2063, 2066, 2070, 2072, 2078, 2083, 2089, 2092, 2093, 2094, 2096, 2097, 2098, 2099, and 2101. Model number 6258383: Serial numbers: 1014, 1015, 1034, 1044, 1045, 1050, 1054, 1061, 1067, 1073, 1090, 1091, 1099, 1101, 1102, 1103, 1109, 1115, 1122, 1126, 1128, 1132, 1133, 1137, 1138, 1141, 1142, 1143, 1147, 1152, 1156, 1157, and 1162.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
Recall of Bicor HiP XRay System
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Manufacturer
Siemens Medical Solutions USA, Inc
Manufacturer Address
Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
English
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