SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Device Model # 10496180 Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813,100814,221129,130326,221192,130201,220930,130438,102113,130635,130377,130125,130546,130322,101309,101503,220743,102013,130575
- 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:
- Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Product Codes/Lot Numbers:
Device Model # 10496180 Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813,100814,221129,130326,221192,130201,220930,130438,102113,130635,130377,130125,130546,130322,101309,101503,220743,102013,130575
Distribution:
Distributed in: CA, NY, TX, OH, CO, NE, NJ, FL, IL, MO, PA, ND
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2107-2016
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