Selenia Full Field Digital Mammography System with software versions 5 — Class II medical device recall Z-2301-2013
Terminated recall by Hologic, Inc., reported 2013-10-09, distributed in AL, AR, CA, CO, FL, IL, KY, LA…. Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently
| Recall number | Z-2301-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Danbury, CT, United States |
| Recall initiated | 2013-09-06 |
| Classified | 2013-09-30 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2013-12-13 |
| Distributed | AL, AR, CA, CO, FL, IL, KY, LA, NC, NE, NJ, NY, OH, PA, TN, TX, UT, WA, WV |
| Countries outside the US | CA, DK, IR, IT, MX, TW |
| Quantity | 62 systems |
| Reason classes | software |
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
Reason for recall
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2301-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.