Recall Z-1370-2012
Hologic, Inc. · initiated February 28, 2012
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.
Codes / lots: software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859
Reason for recall
SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
FDA-determined 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.
Details
- Recall number
- Z-1370-2012
- Initiated
- February 28, 2012
- Posted by FDA
- April 5, 2012
- Terminated
- May 7, 2012
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 7 units
- Distribution
- Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.
- Recalling firm
- Hologic, Inc., Bedford, MA