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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 April 04, 2016
Create Date March 19, 2017
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-1486-2017
Recall Event ID 76431
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Cardio software.
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, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.
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		 Cardio study list does not show STAT studies without refreshing.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated 7/11/2016.
Quantity in Commerce 217 sites potentially have the affected versions
Distribution Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government 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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