Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Medical Systems, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2149-2026
Related Recalls
Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Allia IGS Pulse angiographic X-ray system
GE Medical Systems
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Allia Moveo angiographic X-ray system
GE Medical Systems
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.