Recall Z-0685-2019 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Hologic, Inc.
I-View Contrast Enhanced Digital Mammography, ASY-08109
| Date | Dec 6, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123873 | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY Hologic, Inc., Jan 29, 2013 |