CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report

Merge Mammo is a multi-modality recalled by GE Healthcare It

GE Healthcare It is recalling Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that, distributed in 17 states. The recall was initiated on 26 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version 8.0.2

Quantity recalled28 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-0748-2014
FDA event ID: 65366
Recalling firm: GE Healthcare It, Barrington, IL
Classification: Class II
Status: Terminated
Recall initiated: 26 Aug 2013
FDA classified: 14 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

26 Aug 2013	Recall initiated by company
14 Jan 2014	Classified by FDA	+141 days
22 Jan 2014	Published in enforcement report	+8 days

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

Reason for recall

There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This incorrect image display issue could result in an inaccurate reading on the Merge Mammo workstation. This could result in a missed intervention or mis-diagnosis.

Product as listed by the FDA

Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modal softcopy image including the use of prosthetic template overlays, and including mammography. Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.) Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

Where it was distributed

Worldwide Distribution - USA including AK, AR, CA, IA, ID, IL, MI, MS, MT, NJ, NV, NY, OR, PA, SC, TN, WI and Internationally to Israel, Mexico, and Spain.

Alaska Arkansas California Iowa Idaho Illinois Michigan Mississippi Montana New Jersey Nevada New York Oregon Pennsylvania South Carolina Tennessee Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Software version 8.0.2

Where was it sold?

Worldwide Distribution - USA including AK, AR, CA, IA, ID, IL, MI, MS, MT, NJ, NV, NY, OR, PA, SC, TN, WI and Internationally to Israel, Mexico, and Spain.

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.

More recalls from GE Healthcare It

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3 Aug 2016Device	CLASS II	Imagecast Pacs with Centricity Ris-ic versions prior recalled	Ge Healthcare It	Device Malfunction	Nationwide
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