Devices

Device Recall FUJIFILM FDR Visionary Suite with CH200 stationary xray system

Model / Serial
UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001. Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution.
Product Description
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) || The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
1 Event
- Recall of Device Recall FUJIFILM FDR Visionary Suite with CH200 stationary xray system

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.

Manufacturer Address
Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
Manufacturer Parent Company (2017)
FUJIFILM Holdings Corp.
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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