# FDA recall Z-1208-2025

> **INTELERAD MEDICAL SYSTEMS INCORPORATED** · Class II · device recall initiated 2025-02-05.

## Product

IntelePACS (Image Fusion Module) - InteleViewer

## 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.

## 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

## Key facts

- **Recall number:** Z-1208-2025
- **Recalling firm:** INTELERAD MEDICAL SYSTEMS INCORPORATED
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-05
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montreal, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1208-2025

## Citation

> AI Analytics. FDA recall Z-1208-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1208-2025. Source: US FDA. Licensed CC0.

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