Recall Z-1343-2020— Hologic, Inc.

Name: FDA recall Z-1343-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-21

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc., initiated 2020-01-21, terminated 2021-08-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,. 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..

Recalling firm: Hologic, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Terminated: 2021-08-11
Firm location: Danbury, CT, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.