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U.S. Department of Health and Human Services

Class 2 Device Recall Selenia Dimensions Mammography System

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  Class 2 Device Recall Selenia Dimensions Mammography System see related information
Date Initiated by Firm January 21, 2020
Date Posted February 18, 2020
Recall Status1 Terminated 3 on August 11, 2021
Recall Number Z-1343-2020
Recall Event ID 84882
PMA Number P080003 P010025S013 
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
Product Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
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      
Recalling Firm/
Manufacturer		 Hologic, Inc.
36 and 37 Apple Ridge Rd
Danbury CT 06810-7301
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On January 21, 2020, the firm notified affected customers of the recall via hand-delivered Urgent Medical Device Correction letter. Customers were informed that the firm had received reports of the C-arm seizing or dropping during field repairs and cleaning of the systems. In order to ensure continued safe use of the system, Hologic sent field service engineers to customer sites on January 21, 2020, to inspect affected systems. Customers were asked to not use the system until the inspection was completed. If you have any questions, please contact Technical Support at breasthealth.support@hologic.com
Quantity in Commerce 72
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MUE and Original Applicant = HOLOGIC, INC.
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