GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Summary
The FDA issued a Class II for GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System by GE Medical Systems SCS. Reason: 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 We.
Details
Source
Device Recall
External ID
Z-2553-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Lot/Code Info: REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Quantity Affected: 340 servers
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-08
Company
Buc, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 286 device recalls issued in the same week, part of 534 device-related FDA actions this month.
GE Medical Systems SCS has 26 FDA actions in our database, including 10 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems SCS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems SCS have FDA actions?
GE Medical Systems SCS has 26 FDA actions in our database, including 10 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2553-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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