The Recall Desk

FDA (Devices) recall action 66016

GE Healthcare, LLC recalled 3 products on 2013-09-04

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-09-04
Critical
0
Units
—

Why these products were recalled

GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-09-04

    GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2013-09-04

    GE Healthcare Recalls Patient Data Modules Due to Signal Noise

    GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patien
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2013-09-04

    GE Healthcare Recalls TRAM Modules Due to ECG Signal Noise

    GE Healthcare is recalling TRAM Modules because movement of the ECG connector causes signal noise, which may reduce the accuracy of ECG, respiration, and arrhythmia monitoring.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and
    Category
    Distribution
    2 states