Key facts
| Recalling firm | GE Medical Systems SCS |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System |
| Classification | Class II |
| Recall number | Z-2553-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System -- and the recall number Z-2553-2026. If it matches, stop using or distributing it and contact GE Medical Systems SCS or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is GE Medical Systems SCS and the affected product is described in FDA's record as: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2553-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
GE Medical Systems SCS’s FDA history
Argus HQ has recorded 1 total FDA action tied to GE Medical Systems SCS: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System) and recall number Z-2553-2026, then follow GE Medical Systems SCS's recall instructions.
- Has GE Medical Systems SCS had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for GE Medical Systems SCS so far. Argus ingests new FDA enforcement records daily.
- What is the FDA recall number for this event?
- FDA recall number Z-2553-2026.
Know if this happens again — we'll email you.
Free. No spam, just recall alerts for what you tell us to watch.
Related enforcement actions
Full FDA history for GE Medical Systems SCSCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image… by GE Medical Systems SCS. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-ge-medical-systems-scs-z-2553-2026
"FDA Recall Database: Class II Recall: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image… by GE Medical Systems SCS." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-ge-medical-systems-scs-z-2553-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image… by GE Medical Systems SCS." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/recall/fda-recall-ge-medical-systems-scs-z-2553-2026.
@misc{argushq_argushq_ai_recall_fda_recall_ge_medical_systems_scs_z_2553_2026_2026,
title = {FDA Recall Database: Class II Recall: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image… by GE Medical Systems SCS},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-ge-medical-systems-scs-z-2553-2026},
note = {Accessed: August 13, 2026}
}Source: FDA.gov — Recalls ↗