Notice names this product. GE Medical Systems SCS’s GE Healthcare AW Server 3 is named in FDA Class II recall Z-2553-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384. Units affected: 340 servers. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
GE Healthcare AW Server 3
Company / brand
GE Medical Systems SCS
Lot / serial / date codes
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.
Agency product description and boundaries
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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…