Reported Jan 2, 2019 · Terminated
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 36 and 37 Apple Ridge Rd · Danbury, CT · 06810-7301
Is this the product you have?
- I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
- Lot codes and dates
- Model NumberASY-08109
- UDI Number15420045512016 All units
- Amount recalled
- 337 units
Where it was sold
- Nationwide
Why it was recalled
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
This product could cause temporary or reversible health problems — stop using it.
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