IntelePACS (Image Fusion Module) - InteleViewer
FDA device recall Z-1208-2025 · posted 2025-02-21 · Open, Classified
Recall details
- Recalling firm
- 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.
- Action taken
- 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 were performed on Daylight Savings Time dates since 2022. - A software upgrade to eliminate this bug is expected to be released by the end of March 2025. Once available, you will be notified via email. You will then be able to schedule your product upgrade. - Complete and return the acknowledgement form via email to regulatory-affairs@intelerad.com For more information or to ask any questions about this notification, please contact the firm's regulatory affairs department at regulatory-affairs@intelerad.com
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 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, Aus
- Date initiated
- 2025-02-05
- Date posted
- 2025-02-21
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IntelePACS (K192176) | Intelerad Medical Systems Incorporated | 2020-04-02 |