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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic MIV Mammography System

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 Class 2 Recall
Hologic MIV Mammography System
see related information
Date Posted June 03, 2014
Recall Status1 Terminated on August 18, 2014
Recall Number Z-1701-2014
Recall Event ID 68298
Premarket Notification
510(K) Number
K011987 
Product Classification System, X-Ray, Mammographic - Product Code IZH
Product Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Code Information Serial Numbers: 1800314 7263, 180031472, 18002023051PR
Recalling Firm/
Manufacturer
Hologic, Inc.
36 Apple Ridge Rd # 37
Danbury, Connecticut 06810-7301
Manufacturer 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
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
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.
Quantity in Commerce 3 units
Distribution Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZH and Original Applicant = LORAD, A HOLOGIC CO.
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