Agency classClass IIOur severity:High FDA (Devices)·Z-0808-2014·Announced 2014-01-29

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.

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, 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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitoring
Hazard: monitoring-failure
ecg-noise

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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 →

Same manufacturer · GE Healthcare, LLC

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