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U.S. Department of Health and Human Services

Class 2 Device Recall DR Systems Unity PACS software, now known as Merge Unity PACS

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  Class 2 Device Recall DR Systems Unity PACS software, now known as Merge Unity PACS see related information
Date Initiated by Firm April 08, 2016
Date Posted March 09, 2017
Recall Status1 Terminated 3 on March 17, 2017
Recall Number Z-1426-2017
Recall Event ID 76541
510(K)Number K041935  
Product Classification System, image processing, radiological - Product Code LLZ
Product DR Systems Unity PACS software, now known as Merge Unity PACS
Code Information Version 11.0
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		 Reports were missing demographic header information when they were faxed to referring physicians.
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 on April 8, 2016. Nonresponders were issued a second letter dated July 11, 2016. The letter notifies the customer of the issue, makes them aware of a workaround, and informs them a fix is 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 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 8, 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. The recalling firm reported emails will be tracked for delivery confirmation. For further questions please call ( 877) 741-5369.
Quantity in Commerce 9 sites potentially have the affected version
Distribution US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = DR. SYSTEMS, INC.
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