IntelePACS recall: Software Issue
IntelePACS (Image Fusion Module) - InteleViewer
Why was IntelePACS recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
- Product
- IntelePACS (Image Fusion Module) - InteleViewer
- Recalling firm
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Quantity
- 88
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH, WY, CA, SC, AL, AR, IN, MD, CO, TN, IL, NJ, OH, MN, WV, KE, NE, VA, WA, GE, WI and the countries of New Zealand, Canada, Australia
- Recall date
- March 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)