I-View Contrast Enhanced Digital Mammography, ASY-08109 recallZ-0685-2019 · Hologic, Inc. · initiated Dec 6, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
FDA root cause category: Software design
What the company is doing
Hologic issued letter on 12/6/2018 USPS Certified Mail to customers to inform them of this product correction, and Hologic asks customers to only use I-View for patients with known lesions and confirm the image quality is of acceptable diagnostic quality.Hologic will scheduling appointments to recalibrate the systems for contrast enhanced digital mammography.
Recall details
- Recall number
- Z-0685-2019
- Status
- Terminated
- Initiated by the company
- Dec 6, 2018
- Recalling firm
- Hologic, Inc.
- Quantity
- 337 units
- Product code
- MUE
- FDA submissions
- K123873
- 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 Saudi Arabia Singapore Slovakia South Africa Spain Switzerland Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
Product description
I-View Contrast Enhanced Digital Mammography, ASY-08109
Code information (models, lots, serial numbers)
Model Number: ASY-08109 UDI Number: 15420045512016 All units
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- I -View™ Contrast Enhanced Digital Mammography ASY-08109Hologic, Inc. · Full field digital, system, x-ray, mammographic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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