The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Centricity PACS versions: 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 3.2 SP8; 4.0; 4.0.1; 4.0 SP3
- 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:
- GE Healthcare
- Reason for Recall:
- It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more, but not all, images in
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure.
Product Codes/Lot Numbers:
Centricity PACS versions: 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 3.2 SP8; 4.0; 4.0.1; 4.0 SP3
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1665-2014
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