Z-1343-2020 Class II Terminated
FDA device recall Z-1343-2020 was initiated by Hologic, Inc. on January 21, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 11, 2021). Affected quantity: 72.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 21, 2020
- Termination Date
- August 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72
Product Description
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Serial Numbers 81002143175 81002143176 81002143177 81003143178 81003143179 81003143180 81003143181 81003143182 81003143183 81003143184 81003143185 81003143186 81003143187 81003143188 81003143189 81003143190 81003143191 81003143192 81003143193 81003143194 81003143195 81003143196 81003143197 81003143198 81003143199 81003143200 81003143201 81003143202 81003143203 81003143204 81003143205 81003143206 81003143207 81003143208 81003143209 81003143210 81003143211 81003143212 81003143213 81003143214 81003143215 81003143216 81003143217 81003143218 81003143219 81003143220 81003143221A 81003143222A 81003143223 81003143224A 81003143225 81003143226 81003143227 81003143228 81003143229 81003143230 81003143231 81003143232 81003143234 81003143235 81003143236 81003143237 81003143238 81003143239 81003143240 81003143241 81003143242 81003143243 81003143244 81003143245 81003143246A 81003143247