Class 2 Device Recall GE Centricity PACS RA1000 Workstation Software

• Date Initiated by Firm: September 25, 2009
• Date Posted: November 24, 2009
• Recall Status: Terminated on May 25, 2012
• Recall Number: Z-0456-2010
• Recall Event ID: 53462
• 510(K)Number: K043415
• Product Classification: Radiological Image Processing System - Product Code LLZ
• Product: GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.
• Code Information: Software versions 1.0.x, 2.0.x, 2.1.x, and 3.0.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: There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
• FDA Determined Cause: Software design
• Action: GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated September 23, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers, to the attention of the Hospital Risk Manager, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator, on 9/25/09. The letters advised the users of the patient safety issues associated with the use of GE Centricity PACS related to unintentionally adding new images to an approved exam; deletion of images from PACS if Cancel Checked or Cancel Selected is chosen in the CA Tool - Archive Queue; inadvertently getting two or more exams out of sync with the corresponding reports resulting in the RIS-IC reports being associated with the wrong patients exam; and when rejecting a duplicate image(s) from an unspecified exam that is still in the Arrived or Verified status, the duplicate image(s) is also rejected from the Dictated, Transcribed, or Completed status exam. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed 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 847-939-1479. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issues and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.
• Quantity in Commerce: 1,188 units
• Distribution: Worldwide Distribution -- United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
• 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