IntelePACS (Image Fusion Module) - InteleViewer
Summary
The FDA issued a Class II for IntelePACS (Image Fusion Module) - InteleViewer by INTELERAD MEDICAL SYSTEMS INCORPORATED. Reason: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Stan.
Details
Source
Device Recall
External ID
Z-1208-2025
Action Date
2025-03-05
Status
Ongoing
Category
device
Product Description
IntelePACS (Image Fusion Module) - InteleViewer
Lot/Code Info: UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
Quantity Affected: 88
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-05
Company
Montreal, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
INTELERAD MEDICAL SYSTEMS INCORPORATED has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (INTELERAD MEDICAL SYSTEMS INCORPORATED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INTELERAD MEDICAL SYSTEMS INCORPORATED have FDA actions?
INTELERAD MEDICAL SYSTEMS INCORPORATED has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1208-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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