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FDA-Device2026-07-01Class IIPROCESSING DEFECT

GE Healthcare AW Server 3.2 ext.6.5 recalled for patient data mix-up risk in medical imaging

GE
OTHERNationwide distributiondevice

GE Healthcare AW Server 3.2 recalled for wrong patient images risk

GE Healthcare's AW Server 3.2 ext.6.5 has a software issue that can cause the system to display a previous patient's medical images instead of the correct patient's images when launching certain applications. There is no warning or error message when this happens. If a radiologist or clinician does not notice the error, they could misread images, make wrong diagnoses, or recommend incorrect treatment.

  • Contact GE Healthcare for a software update or patch instructions
  • When using AW Server, verify the patient name and exam details match your intended selection before reviewing any images
  • Report any suspected cases where wrong patient images were reviewed to your facility's medical records and compliance team
Hazard

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.

Who it affects
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
340 servers
Manufactured in
283 rue de la Miniere, N/A, Buc, N/A, France
Products
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2026

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