CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report

I-View¿ Contrast Enhanced Digital Mammography, ASY recalled by Hologic

Hologic is recalling I-View¿ Contrast Enhanced Digital Mammography, ASY-08109, distributed nationwide in the US. The recall was initiated on 6 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: ASY-08109 UDI Number: 15420045512016 All units

Quantity recalled337 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0685-2019
FDA event ID: 81700
Recalling firm: Hologic, Danbury, CT
Classification: Class II
Status: Terminated
Recall initiated: 6 Dec 2018
FDA classified: 27 Dec 2018
Reported: 2 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

6 Dec 2018	Recall initiated by company
27 Dec 2018	Classified by FDA	+21 days
2 Jan 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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