INTELERAD MEDICAL SYSTEMS INCORPORATED: Medical Device Recall in 2025 - (Recall #: Z-0723-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

IntelePACS - InteleConnect / TechPortal

Product Classification:

Class II

Date Initiated: October 17, 2025
Date Posted: December 3, 2025
Recall Number: Z-0723-2026
Event ID: 97868
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.

Status: Ongoing
Product Quantity: 19
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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated