Z-0357-2027

intelerad IntelePACS software

Name: Z-0357-2027 intelerad IntelePACS software
Creator: Intelerad Medical Systems Incorporated
Published: 2026-09-10
License: https://open.fda.gov/license/

Intelerad Medical Systems Incorporated / initiated 2026-09-10 / Open, Classified

FDA source

Recall record

Recall number: Z-0357-2027
Status: Open, Classified
Initiated: 2026-09-10
Posted: 2026-11-04
Recalling firm: Intelerad Medical Systems Incorporated
Product: intelerad IntelePACS software
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out of the system. Additionally, a software issue has been identified that may result in the unintended deletion of image data from an external archive integration.
FDA root cause: Software Design Change
Action: On September 15, 2026 Intelerad, (a GE HealthCare Company) issued a Urgent Medical Device Correction notification to affected consignees via: email. Intelerad ask consignees to take the following actions: 1. Pending corrections by Intelerad, you can continue to use your system by continuing to follow your organization's standard cybersecurity and access control practices until the corrective update is implemented. 2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 3. Please retain this document for your records. 4. Please complete and return the attached acknowledgement form electronically via FMI 88101 Digital Response Form or email, or print, fill out manually, scan, and email to [email protected].
Quantity in commerce: 560 software platforms
Distribution: US: AL FL CO MI CA TX CT AZ NJ IL NC SC MO NH WA KY WY DC NV IN PA AK OR AR KS TN MN MD IA WI HI NY OH VA WV NM GA LA NE UT WA OUS: Australia , Canada, Ireland, New Zealand, South Africa, United Kingdom
Product codes and lots: HIBCC:B228INTELEPACS0/Affected versions: PACS-4-3-4-R20 PACS-4-9-1-R80 PACS-4-12-1-R81 through R90 PACS-4-14-1-R46 through R137 PACS-4-16-1-R50 through R137 PACS-4-17-1-R23 through R117 PACS-4-18-1-R31 through R91 PACS-5-1-1-R17 through R102 PACS-5-2-1-R36 through R93 PACS-5-3-1-R26 through R128 PACS-5-4-1-R15 through R101 PACS-5-5-1-R7 through R89 PACS-5-6-1-R12 through R81 PACS-5-7-1-R2 through R61 PACS-5-8-1-R2 through R42 PACS-5-9-1-R8 through R19

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)