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
    77248
  • Event Risk Class
    Class 2
  • Event Number
    Z-2590-2017
  • 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=155551
  • 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
    Merge pacs did not show unviewed images when the last view was skipped. there is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
  • Action
    Merge Healthcare sent an Urgent Medical Device Recall letter dated May 5, 2017. The letter explains the issue and informs the customer to be aware of the workaround. The customer is also notified a software fix for the issue was released in Merge PACS 7.1.1 (or later). The customer is requested to ensure all users of the product are provided with the notification and if it has been further distributed, to notify downstream customers at once. The letter informs the customer a response is required 15 calendar days after receipt of the recall letter. The enclosed response asks, in part, if the customer is interested in accepting the fix and if not, to state the reason why. The recalling firm will contact all unresponsive customers a second and third time. Methods for contacting the customer may be by phone or email. For further questions, please call (877) 741-5369.

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.