GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3
- 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, LLC
- Reason for Recall:
- GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma
- 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 Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Product Codes/Lot Numbers:
Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2253-2013
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