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Devices
Device Recall Hitachi HI VISION 6500
Model / Serial
Serial Numbers: SE15704205, SE16773210, and SE16935305.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The devices were shipped to consignees in OH, PA, WI.
Product Description
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
Manufacturer
Hitachi Medical Systems America Inc
1 Event
Recall of Device Recall Hitachi HI VISION 6500
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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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