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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a risk-of-harm product (patient monitoring) where reduced detection performance could impact patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling the TRAM Module, a high-acuity patient monitoring device used to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport within hospitals or facilities.
The recall is due to a potential safety issue where intermittent noise appears on ECG and/or Respiration waveforms when the ECG connector moves. This signal noise may result in reduced performance for ECG, Respiration, and arrhythmia detection.
The recall affects 4,807 units distributed worldwide, including the United States (excluding North Dakota) and numerous international locations. Healthcare facilities should contact GE Healthcare for instructions on how to address the issue.
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…
- 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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