International Medical Devices Database

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.

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Type of Event
Recall
Event ID
75161
Event Risk Class
Class 2
Event Number
Z-0118-2017
Event Initiated Date
2011-10-19
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=149492
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
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Action
Merge sent an Urgent Medical Device Recall dated January 28, 2016 to affected customers via email and certified mail if no email address was available. The letter identified the affected product, problem and actions to be taken. For questions Customer Service at 877-741-5369 or support@merge.com.

Device

CADstream software

Model / Serial
Versions prior to 5.2.6
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
CADstream software || Product Usage: || CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
Manufacturer
Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.

Manufacturer Address
Merge Healthcare, Inc., 900 Walnut Ridge Dr, Hartland WI 53029-8347
Manufacturer Parent Company (2017)
International Business Machines Corp.
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of CADstream software

What is this?

Device

CADstream software

Manufacturer

Merge Healthcare, Inc.