Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IView Contrast Enhanced Digital Mammography, ASY08109

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall IView Contrast Enhanced Digital Mammography, ASY08109 see related information
Date Initiated by Firm December 06, 2018
Create Date December 27, 2018
Recall Status1 Terminated 3 on April 24, 2020
Recall Number Z-0685-2019
Recall Event ID 81700
510(K)Number K123873  
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
Product I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Code Information Model Number: ASY-08109 UDI Number: 15420045512016 All units
Recalling Firm/
Manufacturer		 Hologic, Inc.
36 and 37 Apple Ridge Rd
Danbury CT 06810-7301
For Additional Information Contact Same
203-207-4500
Manufacturer Reason
for Recall		 Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUE and Original Applicant = HOLOGIC, INC.
-
-