Hologic I-View Contrast Enhanced Mammography Recall: Calibration Issue

Take action

Contact the company & request your remedy

Recalling firmHologic, Inc.36 and 37 Apple Ridge Rd · Danbury, CT 06810-7301

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

Is there a specific model number for this recall?

Yes, the model number is ASY-08109.

Do I need to stop using this device immediately?

The recall remedy is not specified, so there is no immediate action required beyond contacting Hologic.

What could happen if I use this device?

The calibration issue may cause contrast to not be visible in subtracted mammography images, potentially leading to missed or inaccurate breast cancer detection.

Take action

Contact Hologic

We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0685-2019 — Hologic Hologic

Hello,

I own a Hologic that is covered by recall Z-0685-2019 from Hologic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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.

Hologic, Inc. recalls I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Lower-risk recall