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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Cardio software

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 Class 2 Device Recall Merge Cardio softwaresee related information
Date Initiated by FirmSeptember 22, 2015
Create DateMarch 21, 2017
Recall Status1 Terminated 3 on August 08, 2019
Recall NumberZ-1517-2017
Recall Event ID 76719
510(K)NumberK051649 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Code Information Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactMerge Service and Support
877-741-5369
Manufacturer Reason
for Recall		Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
FDA Determined
Cause 2		Software design
ActionOn 9/22/2015, the recalling firm issued letters dated 9/8/2015 and flagged "PRODUCT INFORMATION" via email to their customers. The recalling firm also issued letters dated 3/28/2016 via email the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A letter dated 7/11/2016 was issued to nonresponders.
Quantity in Commerce89 sites potentially have the affected software
DistributionUS Nationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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