Events

Recall of Device Recall Merge PACS

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

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
    77249
  • Event Risk Class
    Class 2
  • Event Number
    Z-2591-2017
  • Event Initiated Date
    2017-05-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155552
  • 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
    When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. this may cause a misdiagnosis.
  • Action
    Merge sent an Urgent Medical Device Recall letter dated May 5, 2017, to all affected customers. Customers were instructed to be aware of the following workaround: Do not have the simple close study red x icon available in the reading physicians toolbars. This will force them to set status on close which also presents the warning Not all images have been reviewed, do you want to set status anyway and close study or continue reviewing unviewed images? YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED By replying to this notification, you will be taking the necessary steps to ensure that the issue listed in this document will be resolved. Please reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-6369.

Device

Device Recall Merge PACS
  • Model / Serial
    Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.