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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 FirmFebruary 09, 2016
Date PostedSeptember 01, 2016
Recall Status1 Terminated 3 on August 24, 2017
Recall NumberZ-2709-2016
Recall Event ID 75027
510(K)NumberK051649 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Code Information Versions 10.1 and 10.1.1
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactCarol Nakagawa
800-724-5970 Ext. 8027
Manufacturer Reason
for Recall		A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
FDA Determined
Cause 2		Software design
ActionMERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions, please call (800) 724-5970 ext. 8027.
Quantity in Commerce116 customers potentially have the affected versions
DistributionNationwide 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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