FDA recall, , Moderate risk
GE Healthcare AW Server 3.2 ext.6.5
The AW Server may open the previous patient's exam instead of the intended one, potentially leading to misdiagnosis.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems SCS, located in Buc, France, is recalling its GE Healthcare AW Server 3.2 ext.6.5, a Radiological Image Processing System, because of a context synchronization issue.
When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application such as Volume Viewer, the application may open the previous patient's exam instead of the intended one. The recall began on May 8, 2026, and was added to the FDA's Enforcement Report on June 24, 2026.
The product is distributed worldwide, including nationwide in the United States and in countries such as Algeria, Australia, Brazil, Canada, France, Germany, India, Japan, and the United Kingdom. The recall covers 340 servers.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
- UDI-DI
- 00840682102384
Recall details
- Company began the recall
- Sold in
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.
- Company
- GE Medical Systems SCSBuc, France
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99042
- Recall number
- Z-2553-2026
- Quantity recalled
- 340 servers
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
