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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Cardio

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  Class 2 Device Recall Merge Cardio see related information
Date Initiated by Firm April 04, 2016
Date Posted March 08, 2017
Recall Status1 Terminated 3 on March 20, 2017
Recall Number Z-1415-2017
Recall Event ID 76401
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Code Information Version 9.0.9 and earlier using EchoIMS.
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
Manufacturer Reason
for Recall
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
FDA Determined
Cause 2
Software design
Action Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail on April 4, 2016. A letter was issued to nonresponders on July 11, 2016. The letter notifies the customer of the issue, informs them of the workaround, and that no further action was being taken to correct the issue, therefore, the customer needs to be aware of the possible behavior. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. For further information please call (877) 741-5369.
Quantity in Commerce 17 sites potentially have the affected versions
Distribution US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
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