Devices

Device Recall Diagnostic Ultrasound Unit

Model / Serial
Serial Numbers: 11743701 to 11743705 11837701 to 11837705 11906701 to 11906705 12006701 to 12006710 12124701 to 12124710 12315701 to 12315705 12427801 to 12427805
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
Product Description
EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.
Manufacturer
Hitachi Medical Systems America Inc
1 Event
- Recall of Device Recall Diagnostic Ultrasound Unit

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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