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Devices
Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System
Model / Serial
Serial Numbers: C322- to C546; and C746 to C772
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The devices were distributed to consignees located throughout the United States.
Product Description
Hitachi AIRIS II MRI System
Manufacturer
Hitachi Medical Systems America Inc
1 Event
Recall of Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System
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Manufacturer
Hitachi Medical Systems America Inc
Manufacturer Address
Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
Manufacturer Parent Company (2017)
Hitachi Ltd
Source
USFDA
Language
English
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