InteleRad's IntelePACS Image Fusion Module may calculate Standard Uptake Value incorrectly during Daylight Saving Time transitions, risking incorrect PET/CT diagnoses. Affected devices require software update.
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.
InteleRad's IntelePACS Image Fusion Module software has a bug that causes incorrect Standard Uptake Value calculations for PET/CT scans during Daylight Saving Time transitions. This could lead to wrong medical diagnoses if the software error affects scan interpretation.
The software bug causes incorrect Standard Uptake Value (SUV) calculations for PET/:CT scans only when Daylight Saving Time transitions occur. This error may lead to misdiagnosis if the incorrect SUV values affect medical interpretation.
Medical facilities using IntelePACS Image Fusion Module versions 5-6-1-P23 and later may be affected. Patients undergoing PET/CT scans during DST transitions could face incorrect diagnosis risks.
Check if your IntelePACS Image Fusion Module has device version 5-6-1-P23 or later. The product was sold with UDI-DI: B228INTELEPACS0.
Verify your IntelePACS Image Fusion Module version is 5-6-1-P23 or later using the UDI-DI code B228INTELEPACS0.
The software bug causes incorrect Standard Uptake Value calculations for PET/CT scans during Daylight Saving Time transitions, which could lead to misdiagnosis.
Check if your IntelePACS Image Fusion Module has device version 5-6-1-P23 or later with UDI-DI: B228INTELEPACS0.
No action is required for devices not affected by the DST transition issue. Only specific versions with the UDI-DI code are impacted.
We’ve drafted a message you can send InteleRad to request your refund or repair — edit it as you like.
Subject: Recall Z-1208-2025 — InteleRad InteleRad Hello, I own a InteleRad that is covered by recall Z-1208-2025 from InteleRad. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
