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Devices
CXR4 Computed Tomography XRay System
Model / Serial
The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution, including Puerto Rico (PR).
Product Description
Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
Manufacturer
Hitachi Medical Systems America Inc
1 Event
Recall of CXR4 Computed Tomography XRay System
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Manufacturer
Hitachi Medical Systems America Inc
Manufacturer Address
Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
Manufacturer Parent Company (2017)
Hitachi Ltd
Source
USFDA
Language
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