CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
IntelePACS - InteleConnect / TechPortal recalled
Intelerad Medical Systems is recalling IntelePACS - InteleConnect / TechPortal, distributed nationwide in the US. The recall was initiated on 17 Oct 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-0723-2026
- FDA event ID
- 97868
- Recalling firm
- Intelerad Medical Systems, Montreal, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Oct 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 17 Oct 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +40 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
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 - InteleConnect / TechPortal
Where it was distributed
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Nationwide AlabamaArizonaCaliforniaConnecticutFloridaIllinoisIndianaMarylandNorth CarolinaNew JerseyTennesseeWashington
Questions about this recall
Why was it recalled?
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
Which lots are affected?
UDI-DI: B228INTELEPACS0. Version/Dates of Distribution: PACS-5-6-1-R64 through R68/02 Jul 2025 - 10 Sep 2025, PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025, PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025, PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025
Where was it sold?
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
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 (Image Fusion Module) - InteleViewer 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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