Summary
The FDA issued a Class II for IntelePACS - InteleConnect / TechPortal by INTELERAD MEDICAL SYSTEMS INCORPORATED. Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that coul.
Details
Source
Device Recall
External ID
Z-0723-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
Product Description
IntelePACS - InteleConnect / TechPortal
Lot/Code Info: 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
Quantity Affected: 19
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.
Distribution
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-17
Company
Montreal, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
INTELERAD MEDICAL SYSTEMS INCORPORATED has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (INTELERAD MEDICAL SYSTEMS INCORPORATED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INTELERAD MEDICAL SYSTEMS INCORPORATED have FDA actions?
INTELERAD MEDICAL SYSTEMS INCORPORATED has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0723-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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