Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model number 10140000, serial numbers 3118, 3243 and 3309
- 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:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Product Codes/Lot Numbers:
Model number 10140000, serial numbers 3118, 3243 and 3309
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1694-2013
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