IntelePACS (Image Fusion Module) - InteleViewer
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
- 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:
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Reason for Recall:
- A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
IntelePACS (Image Fusion Module) - InteleViewer
Product Codes/Lot Numbers:
UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1208-2025
Related Recalls
IntelePACS - InteleConnect / TechPortal
INTELERAD MEDICAL SYSTEMS INCORPORATED
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.