Recall Z-0727-04 ยท MSX System, Network And Communication, Physiological Monitors
General Electric Medical Systems Information Technology
PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
| Date | Jul 20, 2004 (initiated Feb 27, 2004) |
| Status | Terminated |
| Reason | Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. |
| 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 | Undetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices. |
| Distribution | Nationwide throughout the United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020524 | PATIENTNET MONITORING SYSTEM General Electric Medical Systems Information Techn, Mar 20, 2002 |