Class 2 Device Recall GE Centricity PACS RA1000 Workstation

• Date Initiated by Firm: March 24, 2009
• Date Posted: July 13, 2009
• Recall Status: Terminated on September 06, 2010
• Recall Number: Z-1543-2009
• Recall Event ID: 51252
• 510(K)Number: K043415
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. ; ; The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. 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: Software Versions: Centricity 1.X, 2.0.X, 2.1.X and 3.0.X and PathSpeed 7.X and 8.X.
• 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 may allow the image orientation to be misinterpreted, posing a potential patient safety issue.
• FDA Determined Cause: Software design
• Action: GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation Software Versions 2.1.x and 3.0.x customers via an Urgent Medical Device Correction notice dated March 2, 2009 of the affected device resulting in patient safety issues. The letter provided users with safety instructions until the software is updated. Consignees are requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 1-847-939-1479. Centricity PACS RA1000 Workstation Software Versions PathSpeed 7.x, 8.x, Centricity 1.X and 2.0.X customers were sent separate letters explaining the recall including instructions. There will be no software updates since those software versions are no longer being supported. For questions, call the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.
• Quantity in Commerce: 984 units
• Distribution: Worldwide Distribution - US including Puerto Rico and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria, Belgium, Switzerland, Germany, Denmark, Egypt, Spain, France, Great Britain, Ireland, Israel, Italy, Kuwait, Lebanon, Malta, Netherlands, Portugal, Saudi Arabia, Sweden and Turkey.
• 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