Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IntelePACS software versions 3-8-1 to 4-9-1 Recalled by Intelerad Medical Systems Due to In specific situation a partially truncated file may...

Date: July 3, 2014
Company: Intelerad Medical Systems
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intelerad Medical Systems directly.

Affected Products

IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.

Quantity: 230

Why Was This Recalled?

In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Intelerad Medical Systems

Intelerad Medical Systems has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report