CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
IntelePACS (Image Fusion Module) - InteleViewer recalled
Intelerad Medical Systems is recalling IntelePACS (Image Fusion Module) - InteleViewer, distributed nationwide in the US. The recall was initiated on 5 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1208-2025
- FDA event ID
- 96270
- Recalling firm
- Intelerad Medical Systems, Montreal, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Feb 2025
- FDA classified
- 21 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 5 Feb 2025 | Recall initiated by company | |
| 21 Feb 2025 | Classified by FDA | +16 days |
| 5 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IntelePACS (Image Fusion Module) - InteleViewer
Where it was distributed
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
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaIllinoisIndianaMarylandMichiganMinnesotaNorth CarolinaNebraskaNew HampshireNew JerseyOhioSouth CarolinaTennesseeVirginiaWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Intelerad Medical Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IntelePACS - InteleConnect / TechPortal recalled | Intelerad Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage recalled | Intelerad Medical Systems | Device Malfunction | Nationwide |
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