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U.S. Department of Health and Human Services

Class 2 Device Recall Hologics SecurView DX workstation

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 Class 2 Recall
Hologics SecurView DX workstation
see related information
Date Posted April 05, 2012
Recall Status1 Terminated on May 07, 2012
Recall Number Z-1370-2012
Recall Event ID 61316
Premarket Notification
510(K) Number
K103385 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging modalities. SecurView DX is intended for selection, display, manipulation, filing and media interchange of multimodality images from a variety of different modality systems. It also interfaces to various image storage and printing devices, using DICOM or similar interface standards. The device used with FDA-cleared monitors may be used by a trained physician for display, manipulation, and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multimodality image.
Code Information software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859
Recalling Firm/
Manufacturer
Hologic, Inc.
35 Crosby Dr
Bedford, Massachusetts 01730-1450
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
FDA Determined
Cause 2
DESIGN: Software Design
Action Hologic Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides instructions on how to re-review the stored images and correct any annotation defect. A SecurView DX 7.3.0 Confirmation of Notification form was enclosed for customers to complete and return to the firm via fax at 866-652-8674. Contact Hologic's Help Desk at 1-877-371-4372 for questions regarding this notice.
Quantity in Commerce 7 units
Distribution Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.
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 = LLZ and Original Applicant = HOLOGIC, INC.
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