FDA-Device2020-03-04Class II
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Hologic, Inc.
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.
Sold states
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.
Affected count
72
Manufactured in
36 and 37 Apple Ridge Rd, N/A, Danbury, CT, United States
Products
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1343-2020Don't want to check this manually?
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