Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software version: 5.1 to 5.7.200
- 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:
- The wrong patient information may be displayed in the viewer or PowerJacket.
- 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 - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Product Codes/Lot Numbers:
Software version: 5.1 to 5.7.200
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1348-2021
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