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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 software see related information
Date Initiated by Firm March 28, 2016
Create Date December 09, 2016
Recall Status1 Terminated 3 on March 20, 2020
Recall Number Z-0729-2017
Recall Event ID 75825
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Cardio software.
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:  8.30.0, 8.30.1, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, and 10.1.1
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
877-741-5369
Manufacturer Reason
for Recall		 If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).
FDA Determined
Cause 2		 Software design
Action MERE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers via email or via certified mail if they did not have an email address for the customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to respond to the notification using the enclosed form and the return addressed envelope. Customers were also instructed to ensure that all users of the product are provided with the notification and if product was further distributed customers need to identify their customers and notify them at once of the product recall. Customers with questions should send an email to recall@merge.com. For questions regarding this recall call 877-741-5369.
Quantity in Commerce 198 sites potentially have the effected versions
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = CAMTRONICS MEDICAL SYSTEMS
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