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

FDA device recall Z-0748-2014 · posted 2014-01-14 · Terminated

Recall details

Recalling firm

GE Healthcare It

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

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.

Date initiated

2013-08-26

Date posted

2014-01-14

Date terminated

2016-05-16

Location

Barrington, IL

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