Hologic I-View Contrast Enhanced Mammography Recall: Calibration Issue
Hologic recalls I-View Contrast Enhanced Digital Mammography units due to calibration issues affecting contrast visualization in subtracted images. All units are affected.
Lower-risk recall
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Contact the company
What happened, in plain English
Hologic is recalling all I-View Contrast Enhanced Digital Mammography units (model ASY-081:08109) because a calibration problem makes it impossible to see contrast in subtracted mammography images. This could lead to missed or inaccurate breast cancer detection. Read more at govinfonow.com/recall/69380-hologic-i-view-contrast-enhanced-mammography-recall-calibration-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/69380-hologic-i-view-contrast-enhanced-mammography-recall-calibration-issue · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0685-2019
Cite this page
“Hologic I-View Contrast Enhanced Mammography Recall: Calibration Issue.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69380-hologic-i-view-contrast-enhanced-mammography-recall-calibration-issue. Based on FDA recall #Z-0685-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0685-2019%22&limit=1).
Why it’s dangerous
The device has a calibration issue that prevents it from properly visualizing contrast uptake in subtracted mammography images. This could result in missed or inaccurate breast cancer detection if the images are not correctly interpreted.
Who’s affected
Healthcare providers using the I-View system for mammography are affected. Patients receiving mammograms with this model may be at risk of inaccurate results.
How to tell if you have this one
Check for the model number ASY-08109 on the device. All units are affected, so no specific purchase date or location is needed.
- Brand
Hologic- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Hologic for guidance on next steps, as the recall remedy is not specified in the record.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Australia Austria Belgium Brazil Canada China Colombia Ecuador Egypt France Germany Greece Hong Kong India Ireland Israel Italy Japan Korea, Republic of Kuwait Malaysia Mexico Netherlands Pakistan Peru Poland Portugal…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0685-2019 (December 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0685-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.