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Terminated

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

FDA Recall Z-0727-04 · Posted 2004-07-20

Recalling FirmGeneral Electric Medical Systems Information Technology
Recall StatusTerminated
Product CodeMSX
Date Initiated2004-02-27
Date Terminated2005-11-17
Product QuantityUndetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices.

Reason for Recall

Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide throughout the United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020524PATIENTNET MONITORING SYSTEMGeneral Electric Medical Systems Information Techn · 2002-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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