Class 2 Device Recall PatientNet

• Date Initiated by Firm: February 27, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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: 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