Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
- 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:
- Hologic, Inc.
- Reason for Recall:
- Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Product Codes/Lot Numbers:
Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
Distribution:
Distributed in: CA, NY, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1700-2014
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