Z-0685-2019Class II

I-View Contrast Enhanced Digital Mammography, ASY-08109

Name: Z-0685-2019 I-View Contrast Enhanced Digital Mammography, ASY-08109
Creator: Hologic, Inc.
Published: 2018-12-06
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2018-12-06 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of I-View Contrast Enhanced Digital Mammography, ASY-08109 on 2018-12-06. FDA classified it as Class II and gives the reason as "Calibration issue not possible to visualize contrast uptake in the subtracted mammography images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0685-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-06
Posted: 2018-12-27
Terminated: 2020-04-24
Recalling firm: Hologic, Inc.
Product: I-View Contrast Enhanced Digital Mammography, ASY-08109
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: Model Number: ASY-08109 UDI Number: 15420045512016 All units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0685-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0685-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-27

Product code MUE

K123873Class IIContrast Enhanced Digital MammographyHologic, Inc. / cleared 2013-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)