Synapse PACS Software Versions 5.1 and higher
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
- 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:
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for Recall:
- There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Synapse PACS Software Versions 5.1 and higher
Product Codes/Lot Numbers:
Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0878-2021
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