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U.S. Department of Health and Human Services

Class 2 Device Recall Merge LIS

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  Class 2 Device Recall Merge LIS see related information
Date Initiated by Firm April 15, 2016
Date Posted May 25, 2017
Recall Status1 Terminated 3 on March 13, 2019
Recall Number Z-2628-2017
Recall Event ID 77299
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Merge LIS software. The firm name on the label is Merge Healthcare.

Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
Code Information Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4
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		 There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
FDA Determined
Cause 2		 Software design
Action Merge Healthcare issued a letter dated April 15, 2017, via email or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround, and lets them know a fix is being planned and they will be notified once it 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 are 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 29, 2016. For further questions, call (877) 741-5369.
Quantity in Commerce 638 sites have the potentially affected versions
Distribution Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/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.
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