Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Class I - Dangerous 🏥 Medical Devices
Recalled: June 23, 2022 DICOM Grid, Inc. d/b/a Ambra Health Diagnostic Equipment
Nationwide
What Should You Do?
- Check if you have this product: UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
- 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:
- DICOM Grid, Inc. d/b/a Ambra Health
- Reason for Recall:
- A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Product Codes/Lot Numbers:
UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1818-2022