Recall Z-1343-2020 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Hologic, Inc.
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
| Date | Feb 18, 2020 (initiated Jan 21, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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@holo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.