FDA-Device2014-06-11Class II
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.
Hologic, Inc.
Hazard
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
Sold states
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Affected count
11 units
Manufactured in
36 Apple Ridge Rd # 37, Danbury, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1700-2014Don't want to check this manually?
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