Z-2301-2013Class II

Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field...

Name: Z-2301-2013 Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field...
Creator: Hologic, Inc.
Published: 2013-09-06
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2013-09-06 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital... on 2013-09-06. FDA classified it as Class II and gives the reason as "Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated 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-2301-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-06
Posted: 2013-09-30
Terminated: 2013-12-13
Recalling firm: Hologic, Inc.
Product: Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Root cause tag: software
FDA root cause: Software design
Action: Hologic sent an Urgent Medical Device Recall letter dated September 5, 2013, by Certified Mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised how to avoid loss of images until Hologic corrects the problem. A software upgrade to customers who are connected to Hologic Connect who have already been connected remotely and customers who have already been connected via a Service Call will receive notification of the problem and the date the system was remotely corrected notified by Certified Mail. A Dealer notification issued by certified mail to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00072. Selenia software version 5.2 will implement a double safeguard to both guarantee a 28 day retention period, as well as ensure images are removed in a least recently used order. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
Quantity in commerce: 62 systems
Distribution: Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.
Product codes and lots: Software versions 5.0.x and 5.1.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2301-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2301-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

Product code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)