Z-0723-2026Class II

IntelePACS - InteleConnect / TechPortal

Name: Z-0723-2026 IntelePACS - InteleConnect / TechPortal
Creator: Intelerad Medical Systems Incorporated
Published: 2025-10-17
License: https://open.fda.gov/license/

Intelerad Medical Systems Incorporated / initiated 2025-10-17 / Open, Classified / root cause: software

FDA source

INTELERAD MEDICAL SYSTEMS INCORPORATED began a recall of IntelePACS - InteleConnect / TechPortal on 2025-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0723-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-17
Posted: 2025-11-26
Recalling firm: Intelerad Medical Systems Incorporated
Product: IntelePACS - InteleConnect / TechPortal
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 10/17/2025, correction notices were emailed to customers who were asked to do the following: 1. Schedule Feature Release Upgrade (FRU) update immediately with the firm's Customer Success Manager (CSM). 2. Interim Mitigation: Until the update is applied, please advise all staff to verify the 'Relevant Clinical Info' field after any Case Editor modifications and consider temporarily documenting critical clinical information in alternative fields as backup. 3. complete and return the Acknowledgement Form via email to [email protected]. For more information or to ask any questions about the notification contact the firm's regulatory affairs department at [email protected]
Quantity in commerce: 19
Distribution: US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0723-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code LLZ

K192176Class IIIntelePACSIntelerad Medical Systems Incorporated / cleared 2020-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)