I-View¿ Contrast Enhanced Digital Mammography — Class II medical device recall Z-0685-2019
Terminated recall by Hologic, Inc., reported 2019-01-02, distributed nationwide. Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
| Recall number | Z-0685-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Danbury, CT, United States |
| Recall initiated | 2018-12-06 |
| Classified | 2018-12-27 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, CO, DE, EC, EG, ES, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, KW, MX, MY, NL, PE, PK, PL, PT, SA, SG, SK, TH, TR, TW, ZA |
| Quantity | 337 units |
| UPC / GTIN / UDI-DI | 15420045512016 |
| Model numbers | ASY-08109 |
Product
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Reason for recall
Calibration issue not possible to visualize contrast uptake in the subtracted mammography 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-0685-2019. 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.