Class 2 Device Recall GE Healthcare

• Date Initiated by Firm: May 08, 2026
• Date Posted: June 24, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2553-2026
• Recall Event ID: 99042
• 510(K)Number: K081985
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
• Code Information: REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
• FEI Number: 1000284313
• Recalling Firm/ Manufacturer: GE Medical Systems SCS; 283 rue de la Miniere; Buc France
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
• FDA Determined Cause: Software design
• Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 5/8/2026 by letter delivered via traceable means. The notice explained the issue, potential risk to patient, and requested the following: "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the device by following the instructions below: " Ensure that users verify the correct patient identity (including name, patient ID, and date of birth) and confirm that the selected study matches the intended patient and clinical context prior to reviewing or interpreting imaging studies. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via this FMI 80193 Digital CRF or print, fill out manually, scan, and email to Recall.80193@gehealthcare.com." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 340 servers
• Distribution: Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ