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Terminated

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

FDA Recall Z-1343-2020 · Posted 2020-02-18

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeMUE
Date Initiated2020-01-21
Date Terminated2021-08-11
Product Quantity72

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.

Firm 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 [email protected]

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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