Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
USRevolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
Recalling Firm: GE Medical Systems, LLC
Motivo del Retiro / Peligro
TranslatedGE 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
TranslatedRevolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98738 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN |
| Postal code | 53188-1615 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 33 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260326 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
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 GuideQ1:What should I do immediately if I own or bought Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23?
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.
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🚨 SAFETY ALERT: GE Medical Systems, LLC - Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 Check if your household is affected: https://therecallfile.com/es/recalls/revolution-apex-elite-x-ray-computed-tomography-model-number-5590000-2/FDA-Z-2151-2026
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