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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Cardio with software version 10.1 LA

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  Class 2 Device Recall Merge Cardio with software version 10.1 LA see related information
Date Initiated by Firm October 26, 2015
Create Date December 28, 2015
Recall Status1 Terminated 3 on July 22, 2016
Recall Number Z-0555-2016
Recall Event ID 72661
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Cardio with software version 10.1 LA.
Code Information Merge Cardio with software version 10.1 LA.  Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.  
Recalling Firm/
Manufacturer
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact n/a
262-367-0700
Manufacturer Reason
for Recall
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
FDA Determined
Cause 2
Process control
Action Consignees were either contacted via phone 9/2015 or in person 7/31/2015. The customer communications involved the need to upgrade the consignees software. Merge Healthcare did not script the conversations because they opted to hold one-on-one management level discussions to carefully explain the importance of moving to the Generally Available (GA) release.
Quantity in Commerce 1
Distribution Distributed in the states of IL, NC, and VT.
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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