GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number System ID 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367BU0 HCAALL630 00000656468BU6 5973XR0014 00000656469BU4 5973XR0013 657273BU9 936539CL5 Not Available 082416040067
- 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 Healthcare
- Reason for Recall:
- GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Product Codes/Lot Numbers:
Serial Number System ID 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367BU0 HCAALL630 00000656468BU6 5973XR0014 00000656469BU4 5973XR0013 657273BU9 936539CL5 Not Available 082416040067
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1984-2015
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