Devices

Device Recall ASPIRE Cristalle

Model / Serial
FDR MS-3500 : S/N- 76221095 or earlier
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution and Internationally to Mexico.
Product Description
ASPIRE Cristalle (FDR MS-3500) Mammography machine || The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
1 Event
- Recall of Device Recall ASPIRE Cristalle

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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