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Terminated

Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810

FDA Recall Z-1546-2008 · Posted 2008-05-28

Recalling FirmLorad, A Hologic, Inc.
Recall StatusTerminated
Product CodeMUE
Date Initiated2008-02-28
Date Terminated2009-02-03
Product Quantity73 units

Reason for Recall

Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.

Firm Action

Consignees were notified by an Urgent Recall Notice sent on 3/21/08. The letter informed users that representatives were dispatched to all locations and they have corrected the magnification factor problem. The letter instructed users to re-evaluate any cases read using CAD from the period of installation until the date of system correction. The letter also instructed users that only images read with CAD markers are affected. The letter requests users to return a confirmation of notification. For additional information, contact 1-877-371-4372.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution including USA and countries of Canada and the 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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