Class 2 Device Recall Merge OfficePACS

• Date Initiated by Firm: January 30, 2016
• Date Posted: July 08, 2016
• Recall Status: Terminated 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: 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