Reported Dec 3, 2025 · Ongoing
IntelePACS - InteleConnect / TechPortal
Intelerad Medical Systems Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INTELERAD MEDICAL SYSTEMS INCORPORATED · 800, Boul. de Maisonneuve Est · Montreal, N/A · N/A
Is this the product you have?
- IntelePACS - InteleConnect / TechPortal
- Lot codes and dates
- UDI-DIB228INTELEPACS0
- Version/Dates of DistributionPACS-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
- Amount recalled
- 19
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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