FDA DeviceClass II

IntelePACS - InteleConnect / TechPortal

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.

From the FDA notice · Read the official notice ↗ · All Intelerad recalls

What to do

The agency's notice has the remedy and who to contact.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
IntelePACS - InteleConnect / TechPortal
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
19
Illnesses reported
None reported
Manufactured in
800, Boul. de Maisonneuve Est, 12th floor, Montreal, N/A, Canada
Classification
Class II
Recall number
Z-0723-2026

In the FDA's words

Description
IntelePACS - InteleConnect / TechPortal 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. 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 Distribution: US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC. Affected quantity: 19
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.

More from Intelerad

See all

Related topics