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U.S. Department of Health and Human Services

Class 2 Device Recall Merge (Cedara) Mammo

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 Class 2 Recall
Merge (Cedara) Mammo
see related information
Date Posted January 14, 2014
Recall Status1 Open
Recall Number Z-0748-2014
Recall Event ID 65366
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
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.
Code Information Software version 8.0.2
Recalling Firm/
GE Healthcare It
540 W Northwest Hwy
Barrington, Illinois 60010-3051
For Additional Information Contact GE Healthcare Remote Online Center
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = CEDARA SOFTWARE CORP.