Z-1370-2012

Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other...

Name: Z-1370-2012 Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other...
Creator: Hologic, Inc.
Published: 2012-02-28
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2012-02-28 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging modalities. SecurView DX is intended for... on 2012-02-28. The reason FDA records is "SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1370-2012
Status: Terminated
Initiated: 2012-02-28
Posted: 2012-04-05
Terminated: 2012-05-07
Recalling firm: Hologic, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
Root cause tag: software
FDA root cause: 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.
Product codes and lots: software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859

Product code LLZ

K103385Class IISecurview Dx Diagnostic WorkstationHologic, Inc. / cleared 2011-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)