FDA Medical devices recall ·
IntelePACS (Image Fusion Module) - InteleViewer recall
- Recall number
- Z-1208-2025
- Date
- (initiated February 5, 2025)
- Company / brand
- Intelerad Medical Systems Incorporated
800, Boul. de Maisonneuve Est, Montreal, N/A, Canada - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 88
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IntelePACS (Image Fusion Module) - InteleViewer
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
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
States: Alabama Arkansas Arizona California Colorado Florida Illinois Indiana Maryland Michigan Minnesota North Carolina Nebraska New Hampshire New Jersey Ohio South Carolina Tennessee Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1208-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.