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U.S. Department of Health and Human Services

Class 2 Device Recall IntelePACS

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  Class 2 Device Recall IntelePACS see related information
Date Initiated by Firm July 03, 2014
Date Posted August 19, 2014
Recall Status1 Terminated 3 on January 13, 2016
Recall Number Z-2267-2014
Recall Event ID 68719
510(K)Number K083520  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information software versions 3-8-1 to 4-9-1
Recalling Firm/
Manufacturer		 Intelerad Medical Systems
895 Rue De La Gauchetiere O
Montreal Canada
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form.
Quantity in Commerce 230
Distribution Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = INTELERAD MEDICAL SYSTEMS INCORPORATED
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