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Health & beauty United States Recall (ongoing)

Intelerad Medical Systems Incorporated recalls IntelePACS

IntelePACS - InteleConnect / TechPortal software (UDI-DI B228INTELEPACS0; versions PACS-5-6-1-R64–R68, PACS-5-7-1-R42–R47, PACS-5-8-1-R20–R23, PACS-5-9-1-R1–R3 distributed 26 Jun–25 Sep 2025) sold in 19 units nationwide in AZ, CT, AL, IL, WA, MD, NJ, CA, TN, IN, FL and NC. The software has a bug that can cause loss of data in the Relevant Clinical Info field when modifying studies through the Case Editor in the Technologist Portal or Referring Physician Portal, which could result in loss of clinical information and affect clinical decision-making.

What's being recalled

IntelePACS - InteleConnect / TechPortal

Recalling firm: Intelerad Medical Systems Incorporated, Montreal, N/A, Canada.

How to identify it

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

The hazard

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.

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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