FDA DevicesClass II

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

Publicado: 1 de julio de 2026ID de Retiro: Z-2553-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: GE Medical Systems SCS

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Motivo del Retiro / Peligro

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.

Descripción del Producto e Identificación

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

Additional Source Details

FieldValue
CityBuc
StateN/A
Event id99042
Address 1283 rue de la Miniere
Address 2N/A
Code infoREF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Postal codeN/A
Report date20260701
Product typeDevices
Product quantity340 servers
Reason for recallGE 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260508
Initial firm notificationLetter
Center classification date20260624

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableGE Medical Systems SCS
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionWorldwide 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.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: GE Medical Systems SCS - GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

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https://therecallfile.com/es/recalls/ge-healthcare-aw-server-3-2-ext-6-5-radiological-image-processing-syst/FDA-Z-2553-2026
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