Reported Jan 29, 2014 · Terminated
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, TRAM MODULE, High-acuity patient monitoring
- Product UsageThe 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 monitoring system, to another
- K900540TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is 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 monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration
- K011000The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 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 monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport
- K053121The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. 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 monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport
- Lot codes and dates
- Serial Number
1,948 of 1,948 codes
C7HA1686GC7HA1700GC7HA1701GC7HA1696GC7HA1692GC7HA1688GC7HA1691GC7HA1689GC7HA1687GC7HA1702GB7HA1657GC7HA1683GC7HA1703GC7HA1707GC7HA1709GC7HA1711GD8HA3141GD8HA3154GD8HA3135GD8HA3136GD8HA3149GD8HA3148GD8HA3128GD8HA3134GD8HA3152GD8HA3140GD8HA3137GD8HA3144GH3S20070GH3S20072GJ3S20073GJ3S20075GJ3S20078GJ3S20084GJ3S20089GJ3S20090GJ3S20093GJ3S20085GA4S20482GA4S20471GG4S21111GG4S21108GG4S21112GG4S21090GG4S21106GF5HB0489GE5HB0418GF5HB0493GF5HB0491GF5HB0468GF5HB0497GF5HB0478GE5HB0459GC5HB0346GB5HB0261GA6HB0980GA6HB0978GD6HB1379GK7HB4546GK7HB4542G
- Serial Number
- Amount recalled
- 1,948 (1,834 US; 114 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
This product could cause temporary or reversible health problems — stop using it.
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