Recall Z-1208-2025 ยท LLZ System, Image Processing, Radiological
INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS (Image Fusion Module) - InteleViewer
| Date | Feb 21, 2025 (initiated Feb 5, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On 2/5/2025, correction notices were emailed to customers who were asked to do the following: The following work around can be completed for any impacted SUV calculation. The correct SUV values may be obtained in the SUV calculator, as follows: 1. Adjust the administration time and series time in IntelePACS consistent with the actual time of injection and the time of series acquisition. 2. Verify that the calculated elapsed time is correct. 3. Recalculate the SUV in the calculator, this is the correct SUV value. - Customers are asked to review scans and notify the recalling firm if scans we |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192176 | IntelePACS Intelerad Medical Systems Incorporated, Apr 2, 2020 |