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
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