Home / Recalls / Intelerad Medical Systems / Z-2267-2014

Z-2267-2014 Class II Terminated

Recalled by Intelerad Medical Systems — Montreal

Recall Details

Product Type: Devices
Report Date: August 27, 2014
Initiation Date: July 3, 2014
Termination Date: January 13, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 230

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.

Code Information

software versions 3-8-1 to 4-9-1