Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
- 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:
- Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Product Codes/Lot Numbers:
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0875-2026
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