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I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

FDA Recall #Z-0685-2019 — Class II — December 6, 2018

Recall #Z-0685-2019 Date: December 6, 2018 Classification: Class II Status: Terminated

Product Description

I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Reason for Recall

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

Recalling Firm

Hologic, Inc. — Danbury, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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

Code Information

Model Number: ASY-08109 UDI Number: 15420045512016 All units

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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