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GE Healthcare AW Server 3.2 ext.6.5 recallZ-2553-2026 · GE Medical Systems SCS · initiated May 8, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems SCS or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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 [email protected]." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-2553-2026
Status
Open, Classified
Initiated by the company
May 8, 2026
Posted by the FDA
Jun 24, 2026
Recalling firm
GE Medical Systems SCS
Quantity
340 servers
Product code
LLZ
FDA submissions
K081985
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.

Product description

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

Code information (models, lots, serial numbers)

REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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