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IntelePACS - InteleConnect / TechPortal

FDA Recall #Z-0723-2026 — Class II — October 17, 2025

Recall #Z-0723-2026 Date: October 17, 2025 Classification: Class II Status: Ongoing

Product Description

IntelePACS - InteleConnect / TechPortal

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.

Recalling Firm

INTELERAD MEDICAL SYSTEMS INCORPORATED — Montreal, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

19

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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