INTELERAD MEDICAL SYSTEMS INCORPORATED: Medical Device Recall in 2025 - (Recall #: Z-1208-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

IntelePACS (Image Fusion Module) - InteleViewer

Product Classification:

Class II

Date Initiated: February 5, 2025

Date Posted: March 5, 2025

Recall Number: Z-1208-2025

Event ID: 96270

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.

Status: Ongoing

Product Quantity: 88

Code Information:

UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated