Recall Z-2117-2013— GE Healthcare, LLC

Name: FDA recall Z-2117-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-03

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-04-03, terminated 2016-07-25. It names one FDA 510(k) clearance: K053121. 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 monitoring system, to another.. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-04-03
Terminated: 2016-07-25
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K053121 — TRAM MODULEGE Healthcare·cleared 2006-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 monitoring system, to another.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.