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U.S. Department of Health and Human Services

Class 2 Device Recall Merge OfficePACS

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  Class 2 Device Recall Merge OfficePACS see related information
Date Initiated by Firm January 30, 2016
Date Posted July 08, 2016
Recall Status1 Terminated 3 on February 03, 2017
Recall Number Z-2144-2016
Recall Event ID 74522
510(K)Number K033825  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Code Information Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
Recalling Firm/
Manufacturer
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall
Potential data loss occurs as a result of the software archiving not working properly.
FDA Determined
Cause 2
Software design
Action Merge Healthcare sent an Urgent Medical Device Recall letter dated January 26, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to provide a copy of the notification to all users. For additional questions customers were advised to call Merge Customer Service at (87) 741-5369. For questions regarding this recall call 262-367-0700.
Quantity in Commerce 216 sites have the affected software
Distribution The software was distributed nationwide to medical facilities. There was no government/military/foreign 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 = ETRAUMA.COM CORP.
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