Hologic M-IV Mammography System — Class II medical device recall Z-1701-2014
Terminated recall by Hologic, Inc., reported 2014-06-11, distributed in CA, NY, PR, TX. Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency
| Recall number | Z-1701-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Danbury, CT, United States |
| Recall initiated | 2014-05-13 |
| Classified | 2014-06-03 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-08-18 |
| Distributed | CA, NY, PR, TX |
| Countries outside the US | KR |
| Quantity | 3 units |
| Serial numbers | 18002023051PR, 1800314, 180031472, 7263 |
| Model numbers | M4--00001 |
Product
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Reason for recall
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
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-1701-2014. 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.