INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
- 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:
- Toshiba American Medical Systems Inc
- Reason for Recall:
- When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Product Codes/Lot Numbers:
Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0752-2016
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