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U.S. Department of Health and Human Services

Class 2 Device Recall PatientNet

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  Class 2 Device Recall PatientNet see related information
Date Initiated by Firm February 27, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 17, 2005
Recall Number Z-0727-04
Recall Event ID 28410
510(K)Number K020524  
Product Classification System, Network And Communication, Physiological Monitors - Product Code MSX
Product PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
Code Information All PatientNet Central Stations
Recalling Firm/
Manufacturer		 General Electric Medical Systems Information Technology
8200 W Tower Ave
Milwaukee WI 53223-3219
Manufacturer Reason
for Recall		 Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
FDA Determined
Cause 2		 Other
Action Consignees were notified via certified mail, return receipt requested, on Friday, February 27, 2004. GE Field service representatives will upgrade affected PatientNet Central Stations (RVS, IRVS, or Sitelink IRVS) to software version 2.01.
Quantity in Commerce Undetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices.
Distribution Nationwide throughout the United States
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 = MSX and Original Applicant = GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
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