Selenia Dimensions Mammography System — Class II medical device recall Z-1343-2020
Terminated recall by Hologic, Inc., reported 2020-03-04, distributed in AK, AZ, CA, CO, CT, DC, FL, GA…. The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing o
| Recall number | Z-1343-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Danbury, CT, United States |
| Recall initiated | 2020-01-21 |
| Classified | 2020-02-21 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2021-08-11 |
| Distributed | AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, MA, MO, NC, NH, NJ, NY, OH, SD, TX, VA |
| Countries outside the US | BR, CA, CR, CY, DE, ES, FR, GB, IT, KR, KW, NL, OM, PE, RU, SA |
| Quantity | 72 |
| UPC / GTIN / UDI-DI | 15420045505636 |
| Serial numbers | 81002143175, 81002143176, 81002143177, 81003143178, 81003143179, 81003143180, 81003143181, 81003143182, 81003143183, 81003143184, 81003143185, 81003143186, 81003143187, 81003143188, 81003143189, 81003143190, 81003143191, 81003143192, 81003143193, 81003143194, 81003143195, 81003143196, 81003143197, 81003143198, 81003143199 and 47 more |
| Model numbers | ASY-04160 |
Product
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Reason for recall
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
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-1343-2020. 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.