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Hologic, Inc. recalls Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Recalled March 4, 2020 · FDA recall Z-1343-2020 · Hologic
Hazard
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. · FDA Class II
Units
72
Sold at
Domestic distribution to 14 states: AK AZ CA CO CT DC FL GA IA ID IL MA MO NC NH NJ NY OH SD TX VA. Foreign distribution to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.
Description
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
Product
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Manufacturer(s)
Hologic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →