GE Healthcare Recalls TRAM Modules Due to Intermittent ECG Noise
GE Healthcare is recalling 1,948 TRAM Modules because movement of the ECG cable connector causes intermittent noise on ECG and respiration waveforms, potentially reducing monitoring performance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (patient monitoring) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 1,948 TRAM Modules, which are high-acuity patient monitoring devices used for intra-hospital transport. The recall involves 1,834 units in the United States and 114 units distributed internationally.
The recall was initiated due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. This issue may result in reduced ECG, Respiration, and arrhythmia detection performance.
The affected devices are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. They are used to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport within a hospital or facility. The devices are distributed nationwide in the US (excluding SD, VT, and WY) and in numerous international locations.
The recalled product
- 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 monit
- Manufacturer
- GE Healthcare, LLC
Distribution
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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