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U.S. Department of Health and Human Services

Class 2 Device Recall eFilm Workstation

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  Class 2 Device Recall eFilm Workstation see related information
Date Initiated by Firm August 28, 2014
Date Posted October 15, 2014
Recall Status1 Terminated 3 on June 01, 2017
Recall Number Z-0068-2015
Recall Event ID 69295
510(K)Number K020995  K012211  
Product Classification System, image processing, radiological - Product Code LLZ
Product eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System).

Product Usage:
eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.
Code Information versions 4.0 and 4.0.1
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Customer Service
877-741-5369
Manufacturer Reason
for Recall		 There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.
FDA Determined
Cause 2		 Device Design
Action Merge sent an Important Product Information Notice letter, dated August 22, 2014 to consignees. The letter stated the issue, identified affected product, provided instructions, and told of a product update expected to be available by September 15, 2014. Customers with questions should contact Customer Service at 877-741-5369
Quantity in Commerce 2,630
Distribution Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen.
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 = EFILM MEDICAL, INC.
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