HIGHFDA DEVICE

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

GE Medical Systems SCSHealth & Personal CareMedical DevicesREF# (01)00840682102384(10)AWS03D02E6D5GTIN Number 00840682102384

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 8, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 8, 2026
Hazard Level
HIGH
Brand
GE Medical Systems SCS
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
GE Medical Systems SCS
Model numbers
REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 8, 2026

  2. Reported by FDA DEVICE

    July 1, 2026

  3. RecallRadar source check

    July 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems SCS or your healthcare provider for instructions. Notification method: Letter

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Full Description

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System. 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 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.. Classification: Class II. Quantity: 340 servers. 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.

Safety Guide

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Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
REF# (01)00840682102384(10)AWS03D02E6D5
GTIN Number 00840682102384
Affected States
ALL
Report Date
July 1, 2026
Recall Status
ACTIVE