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Devices
Echelon Magnetic Resonance Imaging Device
Model / Serial
Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The recalled unit was distributed to a single customer.
Product Description
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Manufacturer
Hitachi Medical Systems America Inc
1 Event
Recall of Echelon Magnetic Resonance Imaging Device
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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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