Class 2 Device Recall GE Centricity PACSIW

• Date Initiated by Firm: June 15, 2012
• Date Posted: October 30, 2013
• Recall Status: Terminated on June 10, 2016
• Recall Number: Z-0118-2014
• Recall Event ID: 64730
• 510(K)Number: K083018
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
• Code Information: Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8
• Recalling Firm/ Manufacturer: Ge Healthcare It; 540 W Northwest Hwy; Barrington IL 60010-3051
• For Additional Information Contact: GE Healthcare Remote Online Center; 800-437-1171
• Manufacturer Reason for Recall: Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe
• FDA Determined Cause: Software design
• Action: GE Healthcare sent an IMPORTANT PRODUCT INFORMATION letter dated June 15, 2012 to direct accounts informing them of the Auto-Fetch functionality issue and advising them to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171. GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers informing them of all three of the safety issues. The letter again adivsed customers to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. The letter further infomed customers that all three errors can be resolved through the installation of a new version of the software. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171.
• Quantity in Commerce: 847 units
• Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen. Center Recommended Depth - Consumers/User**
• 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