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FDAClass II · Medical device · Recalled July 1, 2026
GE Healthcare AW Server 3 recall — GE Medical Systems SCS
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2553-2026
- Brand
- GE Medical Systems SCS
- Classification
- Class II
- Units affected
- 340 servers
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Affected products
Companies & origin
- Recalling firm location
- Buc, N/A, France
- Firm address
- 283 rue de la Miniere, N/A, N/A
Identifying details (verbatim from the notice)
- Product codes / lots
- REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99042
- Recall initiated
- May 8, 2026
- FDA classified
- June 24, 2026
- FDA report date
- July 1, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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