Events

Recall of Merge RadSuite software

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
    74853
  • Event Risk Class
    Class 2
  • Event Number
    Z-2715-2016
  • Event Initiated Date
    2015-04-09
  • Event Date Posted
    2016-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148606
  • 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 radsuite is used with ipid (issuer of patient id) as a part of the "patient identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
  • Action
    The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.

Device

Merge RadSuite software
  • Model / Serial
    RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled;  (2) Must use IPID morphers  (3) Must Define a Defaultvalue in the IPID Morpher;  (4) Must use the Aggregating Morpher;  (5) Must not set OverwritelfPresent=false; and  (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
  • Product Description
    Merge RadSuite software. Radiological image processing system.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.