Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0727-04

PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx

GE Medical Systems Information Technologies, Inc. / initiated 2004-02-27 / Terminated / root cause: software

General Electric Medical Systems Information Technology began a recall of PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx on . The reason FDA records is "Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0727-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Medical Systems Information Technologies, Inc.
Product
PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
Product code
MSX System, Network And Communication, Physiological Monitors
Reason for recall
Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
Root cause tag
software
FDA root 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
Product codes and lots
All PatientNet Central Stations