Optima XR646 HD. X-Ray imaging system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00195278526892
- 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:
- The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Optima XR646 HD. X-Ray imaging system.
Product Codes/Lot Numbers:
GTIN: 00195278526892
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1046-2025
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