Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software Version: SW VD-10E
- 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:
- Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Product Codes/Lot Numbers:
Software Version: SW VD-10E
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0597-2016
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