Z-0748-2014Class II

Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers...

Name: Z-0748-2014 Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers...
Creator: GE Healthcare It
Published: 2013-08-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-08-26 / Terminated / root cause: software

FDA source

GE Healthcare It began a recall of Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read... on 2013-08-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0748-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-26
Posted: 2014-01-14
Terminated: 2016-05-16
Recalling firm: GE Healthcare
Product: 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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2013, to all affected customers. The letter includes important safety instructions for healthcare providers to refer to that can minimize the chance that an incorrect image will be used in the diagnosis or treatment of a patient. The letter further states that a GE Healthcare service representative will contact the customer to schedule a time to install a software update to version 8.0.2 that will correct the software defect.. Customers with any concerns about this defect or recall are encouraged to contact their local GEHC-IT service representative or the GE Remote Online Center (ROC) Customer Care Center at 1-800-437-1171. For questions regarding this recall call 800-437-1171.
Quantity in commerce: 28 units
Distribution: 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.
Product codes and lots: Software version 8.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0748-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

Product code LLZ

K040468Class IICedara I-Softview and Cedara I-ReadmammoCedara Software Corp. / cleared 2004-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)