Recall Z-2267-2014— Intelerad Medical Systems

Name: FDA recall Z-2267-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-03

Class II · Terminated

Class II FDA medical device recall by Intelerad Medical Systems, initiated 2014-07-03, terminated 2016-01-13. It names one FDA 510(k) clearance: K083520. 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.. 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: Intelerad Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2014-07-03
Terminated: 2016-01-13
Firm location: Montreal, Canada

510(k) clearances named in this recall

1 on FDA's record

K083520 — INTELEPACS, MODEL VERSION 3.X.XIntelerad Medical Systems Incorporated·cleared 2009-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.