Lorad, A Hologic, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Lorad, A Hologic, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345, 28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709, 28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807, 28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014, 28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076, 28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577, 28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339, 28412072602, 29408072073, 28407072007S, 28409030072RF and 28409030077RM.
Products Sold
Serial Numbers: 28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345, 28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709, 28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807, 28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014, 28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076, 28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577, 28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339, 28412072602, 29408072073, 28407072007S, 28409030072RF and 28409030077RM.
Lorad, A Hologic, Inc. is recalling Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, due to Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026