Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
USRevolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Recalling Firm: GE Medical Systems, LLC
Motif du rappel / Danger
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.
Description du produit & Identification
TranslatedRevolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98738 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | UDI-DI: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC |
| Postal code | 53188-1615 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 25 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 Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300?
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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Aperçu
- Entreprise responsableGE Medical Systems, LLC
- StatusOngoing
- Niveau de risqueClass II
- DistributionWorldwide - US Nationwide distribution.
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🚨 SAFETY ALERT: GE Medical Systems, LLC - Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 Check if your household is affected: https://therecallfile.com/fr/recalls/revolution-ascend-computed-tomography-model-numbers-6969000-100-and-69/FDA-Z-2149-2026
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