PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- February 27, 2004
- Posted
- July 20, 2004
- Terminated
- November 17, 2005
- Recall Number
- Z-0727-04
- Quantity
- Undetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices.
- Firm Location
- Milwaukee, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
Distribution
Nationwide throughout the United States
Lot / Code Info
All PatientNet Central Stations
Root Cause
Other
Action Taken
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.
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