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U.S. Department of Health and Human Services

Class 3 Device Recall The Selenia Full Field Digital Mammography System

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  Class 3 Device Recall The Selenia Full Field Digital Mammography System see related information
Date Initiated by Firm February 28, 2008
Date Posted May 28, 2008
Recall Status1 Terminated 3 on February 03, 2009
Recall Number Z-1546-2008
Recall Event ID 47386
PMA Number P010025 
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
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
Code Information 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.
Recalling Firm/
Manufacturer		 Lorad, A Hologic, Inc.
36 Apple Ridge Rd
Danbury CT 06810-7301
For Additional Information Contact Gail Yaeker-Daunis
203-731-8337
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 73 units
Distribution Worldwide Distribution including USA and countries of Canada and the Republic of Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MUE and Original Applicant = HOLOGIC, INC.
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