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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS software. The firm name on the label is Merge Healthcare.

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  Class 2 Device Recall Merge PACS software. The firm name on the label is Merge Healthcare. see related information
Date Initiated by Firm April 04, 2016
Create Date March 09, 2017
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-1431-2017
Recall Event ID 76594
510(K)Number K082144  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge PACS software. The firm name on the label is Merge Healthcare.
Code Information Versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, and 7.0.1
Recalling Firm/
Manufacturer
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service & Support
877-741-5369
Manufacturer Reason
for Recall
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
FDA Determined
Cause 2
Software design
Action Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, to all affected customers via email the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A letter dated February 21, 2017 , was issued was also issued via email or certified mail. The letter notifies the customer of the issue, informs them not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis, and they should be aware of the workaround. The customer is also notified a fix is not yet available, however, the recalling firm is working on correcting the issue and will inform them once a fix is made available. 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 and are they interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. A second letter was issued dated February 21, 2017,via email or certified mail if no email address was available. The letter notified customers a fix was now available and also contained the same information and response form as the first letter. The letter informed the customer a response was required 15 calendar days after receipt of the letter. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.
Quantity in Commerce 248 sites potentially have the affected versions
Distribution USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military 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 = AMICAS, INC.
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