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Lower risk Medical device recall · FDA · Published October 17, 2025

IntelePACS Software Update Causes Clinical Data Loss - Recall

InteleRad's IntelePACS software versions from June to September 2025 may lose clinical data when modifying studies, risking incorrect medical decisions. Affected users should contact for updates.

🇺🇸 FDA recall #Z-0723-2026Medical deviceInteleRad ›
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Recalling firmINTELERAD MEDICAL SYSTEMS INCORPORATED800, Boul. de Maisonneuve Est, 12th floor · Montreal, Canada
✎ GovInfoNow plain-language explainer

InteleRad's IntelePACS software versions from June to September 2025 may lose clinical data when modifying studies, which could lead to incorrect medical decisions. Users should check if they have the affected versions and contact InteleRad for updates. Read more at govinfonow.com/recall/51054-intelepacs-software-update-causes-clinical-data-loss-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51054-intelepacs-software-update-causes-clinical-data-loss-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0723-2026

Cite this page

“IntelePACS Software Update Causes Clinical Data Loss - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51054-intelepacs-software-update-causes-clinical-data-loss-recall. Based on FDA recall #Z-0723-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2026%22&limit=1).

The FDA announced on Oct. 17, 2025, that InteleRad Medical Systems Inc. is voluntarily recalling its IntelePACS - InteleConnect / TechPortal software due to a bug causing data loss in the Relevant Clinical Info field. The agency issued recall number Z-0723-2026 for the Class II device.

How to tell if you have it

  • Brand: InteleRad
  • Product: IntelePACS - InteleConnect / TechPortal
  • UDI-DI: B228INTELEPACS0
  • Versions/Dates: 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)
  • Quantity: 19 units
  • Distribution: US Nationwide, including AZ, CT, AL, IL, WA, MD, NJ, CA, TN, IN, FL, NC

The hazard

According to the FDA, a software bug could cause data loss in the Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal. This loss of clinical information could impact clinical decision-making.

Context

GovInfoNow's records show InteleRad has one other recall on record since Feb. 5, 2025: the IntelePACS Image Fusion Module for incorrect SUV calculations during DST transitions. Other recent recalls of similar products include GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026), Medtronic Restore CP App Model A71100 Software Issue (Nov. 20, 2025), and Intelerad InteleShare Software Recall (Nov. 18, 2025).

How to tell if you have this one

Check if your IntelePACS software version is listed in the distribution dates: PACS-5-6-1-R64 through R68 (July 2025), PACS-5-7-1-R42 through R47 (June 2025), PACS 5-8-1-R20 through R23 (June 2025), or PACS-5-9-1-R1 through R3 (June 2025).

  • Brand
    InteleRad
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify your IntelePACS version by checking the distribution dates listed in the recall notice.

  2. Contact InteleRad

    Reach out to InteleRad for updates or assistance with the software issue.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Connecticut, Florida, Illinois, Indiana, Maryland, New Jersey, North Carolina, Tennessee, Washington.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Oct 17, 202512. FDA classified it Class II: Nov 26, 202523. Published in FDA’s Enforcement Report: Dec 3, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this software dangerous?

The software has a bug that could cause clinical data loss, but it does not cause immediate harm. The risk is low and only affects data accuracy during study edits.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0723-2026 (October 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0723-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA