Events

Recall of Device Recall Merge (Cedara) Mammo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare It.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65366
  • Event Risk Class
    Class 2
  • Event Number
    Z-0748-2014
  • Event Initiated Date
    2013-08-26
  • Event Date Posted
    2014-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118680
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    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
    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.

Device

Device Recall Merge (Cedara) Mammo
  • Model / Serial
    Software version 8.0.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    GE Healthcare It

Manufacturer

GE Healthcare It
  • Manufacturer Address
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA