Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,

FDA device recall Z-1343-2020 · posted 2020-02-18 · Terminated

Recall details

Recalling firm

Hologic, Inc.

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.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

MUE

Quantity affected

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, Cypr

Date initiated

2020-01-21

Date posted

2020-02-18

Date terminated

2021-08-11

Location

Danbury, CT