Company:Intelerad Medical Systems
Date of Enforcement Report: 8/27/2014
Class lI:
PRODUCT
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.
Recall Number Z-2267-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Intelerad Medical Systems, Montreal, CA on 7/3/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
230
DISTRIBUTION
Nationwide and Internationally
___________________________________