RecallRadar

FDA Device recall Z-0723-2026

IntelePACS - InteleConnect / TechPortal

On 2025-12-03 the FDA classified a Class II recall of IntelePACS - InteleConnect / TechPortal by Intelerad Medical Systems, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0723-2026
ClassificationClass II
Statusongoing
Initiated2025-10-17
Published2025-12-03
Last updated2026-09-13 11:57 UTC
CompanyIntelerad Medical Systems
DistributionUS

Product

IntelePACS - InteleConnect / TechPortal

Reason

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.

Identifiers

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…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 history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2026%22

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