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Terminated

Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

FDA Recall Z-1700-2014 · Posted 2014-06-03

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeMUE
Date Initiated2014-05-13
Date Terminated2014-08-18
Product Quantity11 units

Reason for Recall

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

Firm Action

Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.

Root Cause

Component change control

Distribution Pattern

Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.

Official Source

View FDA Recall →

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

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