Devices

Device Recall Hologic Selenia Full Field Digital Mammography System

Model / Serial
Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Product Description
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Manufacturer
Hologic, Inc.
1 Event
- Recall of Device Recall Hologic Selenia Full Field Digital Mammography System

Manufacturer

Hologic, Inc.

Manufacturer Address
Hologic, Inc., 36 Apple Ridge Rd # 37, Danbury CT 06810-7301
Manufacturer Parent Company (2017)
Hologic Inc
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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