| Class 2 Device Recall Hologics SecurView DX workstation | |
Date Initiated by Firm | February 28, 2012 |
Date Posted | April 05, 2012 |
Recall Status1 |
Terminated 3 on May 07, 2012 |
Recall Number | Z-1370-2012 |
Recall Event ID |
61316 |
510(K)Number | K103385 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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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 MA 01730-1450
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For Additional Information Contact | 781-999-7300 |
Manufacturer Reason for Recall | SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images |
FDA Determined Cause 2 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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