Class 2 Device Recall GE Centricity PACS RA1000 Workstation

• Date Initiated by Firm: September 25, 2008
• Date Posted: December 13, 2008
• Recall Status: Terminated on September 06, 2010
• Recall Number: Z-0460-2009
• Recall Event ID: 49458
• 510(K)Number: K043415
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010.; ; The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity" PACS infrastructure.
• Code Information: GE Centricity PACS RA1000 Workstation software versions: 1) Software version 2.1.X (from 2.1.2.1 to 2.1.5.4 inclusive for the patient jacket issue and all 2.1.x releases prior to 2.1.5.1 for the default display protocol issue), and 2) Software version 3.0.X (from 3.0.0.0 to 3.0.3.1 inclusive for the patient jacket issue and all 3.0.x releases prior to 3.0.2 for the default display protocol issue).
• Recalling Firm/ Manufacturer: GE Healthcare Integrated IT Solutions; 540 W Northwest Hwy; Barrington IL 60010-3051
• For Additional Information Contact: GE Customer Care Center; 800-437-1171
• Manufacturer Reason for Recall: Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the curr
• FDA Determined Cause: Software design
• Action: GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation customers via letter (Product Safety Notification) dated 9/25/08 of the software anomalies resulting in patient safety issues involving the patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa. The letter provided the users with safety instructions to follow until the software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-277-5240.
• Quantity in Commerce: 546 units
• Distribution: Worldwide Distribution including USA and countries of Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela.
• 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 = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES