Home / Recalls / Medical Devices
Hologic, Inc. recalls Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full F
Recalled June 11, 2014 · FDA recall Z-1700-2014 · Hologic
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 · FDA Class II
Units
11 units
Sold at
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Description
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
Product
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(s)
Hologic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →