FDA Medical Device Recalls (openFDA)
Hologic, Inc.: I-View Contrast Enhanced Digital Mammography, ASY-08109
- Recall number
- Z-0685-2019
- Recalling firm
- Hologic, Inc.
- Product
- I-View Contrast Enhanced Digital Mammography, ASY-08109
- Status
- Terminated
- Initiated
- 2018-12-06
- Posted
- not on file
- Terminated
- 2020-04-24
- Reason
- Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
- Root cause
- Software design
- Action
- 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.
- Quantity
- 337 units
- 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
- Lot, serial or model codes
- Model Number: ASY-08109 UDI Number: 15420045512016 All units
- 510(k) numbers
- ["K123873"]
- PMA numbers
- not on file
- Product code
- MUE
- Firm FEI
- 1220984
- Firm city
- Danbury
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28