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Devices
Device Recall CXR4CT (including Sceptre P3 PET/CT)
Model / Serial
CXR46201-46214 PC46002-46011
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
Product Description
Hitachi Emission Computed Tomography System || Hitachi CX-4 CT (including SceptreP3 PET-CT)
Manufacturer
Hitachi Medical Systems America Inc
1 Event
Recall of Device Recall CXR4CT (including Sceptre P3 PET/CT)
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Manufacturer
Hitachi Medical Systems America Inc
Manufacturer Address
Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
Manufacturer Parent Company (2017)
Hitachi Ltd
Source
USFDA
Language
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