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Terminated

I-View Contrast Enhanced Digital Mammography, ASY-08109

FDA Recall Z-0685-2019 · Posted None

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeMUE
Date Initiated2018-12-06
Date Terminated2020-04-24
Product Quantity337 units

Reason for Recall

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYHologic, Inc. · 2013-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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