FDA DevicesClass II

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

Publicado: 20 de mayo de 2026ID de Retiro: Z-2150-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

Recalling Firm: GE Medical Systems, LLC

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Motivo del Retiro / Peligro

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

Descripción del Producto e Identificación

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

Additional Source Details

FieldValue
CityWaukesha
StateWI
Event id98738
Address 13000 N Grandview Blvd
Code infoUDI-DI: 00840682118552; Serial Numbers:REVVX2300007CN 443327CN2 REVVX1600034CN REVVX2400004CN REVVX2200047CN 441716CN8 00000440713CN6 REVVX1800043CN 441839CN8 REVVX1700067CN REVVX1800007CN REVVX1800105CN REVVX1800048CN REVVX1900123CN REVVX1800046CN REVVX2000005CN REVVX2200009CN REVVX1600013CN REVVX1700101CN REVVX2200025CN REVVX2100028CN REVVX1900069CN REVVX2100020CN REVVX2100014CN REVVX2100050CN REVVX1600052CN 438902CN9 REVVX1900107CN 438369CN1 REVVX1900018CN REVVX1700071CN REVVX1700082CN 442792CN8 REVVX2200007CN REVVX1700104CN REVVX2000056CN REVVX1900086CN REVVX2200039CN
Postal code53188-1615
Report date20260520
Product typeDevices
Product quantity38 units
Reason for recallGE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260326
Initial firm notificationLetter
Center classification date20260508

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 Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6?

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, LLC
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionWorldwide - US Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: GE Medical Systems, LLC - Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

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https://therecallfile.com/es/recalls/revolution-ct-x-ray-computed-tomography-model-numbers-5590000-and-5590/FDA-Z-2150-2026
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