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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS

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  Class 2 Device Recall Merge PACS see related information
Date Initiated by Firm May 08, 2017
Create Date June 15, 2017
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-2590-2017
Recall Event ID 77248
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, Hartland, WI.
Code Information Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
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		 Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Merge Healthcare sent an Urgent Medical Device Recall letter dated May 5, 2017. The letter explains the issue and informs the customer to be aware of the workaround. The customer is also notified a software fix for the issue was released in Merge PACS 7.1.1 (or later). The customer is requested to ensure all users of the product are provided with the notification and if it has been further distributed, to notify downstream customers at once. The letter informs the customer a response is required 15 calendar days after receipt of the recall letter. The enclosed response asks, in part, if the customer is interested in accepting the fix and if not, to state the reason why. The recalling firm will contact all unresponsive customers a second and third time. Methods for contacting the customer may be by phone or email. For further questions, please call (877) 741-5369.
Quantity in Commerce 47 sites potentially have the affected versions
Distribution USA (nationwide) Distribution .There was no foreign/government/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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