Events

Recall of Device Recall iConnect Access

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
    74734
  • Event Risk Class
    Class 2
  • Event Number
    Z-2531-2016
  • Event Initiated Date
    2016-01-30
  • 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=148347
  • 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
    Studies that are viewed in iconnect access that originate on merge pacs / ortho pacs may not display the correct current patient demographics if there has been a pde (patient / study demographic edit) performed after the images were ingested in pacs.
  • Action
    The recalling firm issued a letter dated 1/28/2016 via e-mail on 1/31/2016 or via certified mail if they did not have an e-mail address for the customer.

Device

Device Recall iConnect Access
  • Model / Serial
    iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • Product Description
    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.