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.
This recall has been terminated (originally issued April 5, 2012).
- Company
- Hologic, Inc.
- Recall Initiated
- February 28, 2012
- Posted
- April 5, 2012
- Terminated
- May 7, 2012
- Recall Number
- Z-1370-2012
- Quantity
- 7 units
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
Distribution
Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.
Lot / Code Info
software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859
Root Cause
Software design
Action Taken
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.