I-View¿ Contrast Enhanced Digital Mammography recall
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Why was I-View¿ Contrast Enhanced Digital Mammography recalled?
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: ASY-08109 UDI Number: 15420045512016 All units
- Product
- I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
- Recalling firm
- Hologic, Inc.
- 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
- Recall date
- January 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)