Z-1208-2025Class II

IntelePACS (Image Fusion Module) - InteleViewer

Name: Z-1208-2025 IntelePACS (Image Fusion Module) - InteleViewer
Creator: Intelerad Medical Systems Incorporated
Published: 2025-02-05
License: https://open.fda.gov/license/

Intelerad Medical Systems Incorporated / initiated 2025-02-05 / Open, Classified / root cause: software

FDA source

INTELERAD MEDICAL SYSTEMS INCORPORATED began a recall of IntelePACS (Image Fusion Module) - InteleViewer on 2025-02-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1208-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-05
Posted: 2025-02-21
Recalling firm: Intelerad Medical Systems Incorporated
Product: IntelePACS (Image Fusion Module) - InteleViewer
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: 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 [email protected] For more information or to ask any questions about this notification, please contact the firm's regulatory affairs department at [email protected]
Quantity in commerce: 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, Australia
Product codes and lots: UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1208-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1208-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-21

Product code LLZ

K192176Class IIIntelePACSIntelerad Medical Systems Incorporated / cleared 2020-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)