GE Healthcare Recalls Dash Patient Monitors Due to ECG Noise
GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because cable movement causes intermittent noise on ECG and respiration waveforms, potentially reducing detection 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 involves a medical device where a defect may reduce the performance of critical monitoring functions (ECG and arrhythmia detection). This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or deaths are mentioned in the source text.
Plain-English summary
GE Healthcare, LLC is recalling the Dash 3000, Dash 4000, and Dash 5000 patient monitoring systems. These devices are intended for use under the direct supervision of a licensed healthcare practitioner to monitor physiologic parameter data on adult, pediatric, and neonatal patients in various medical facilities.
The recall is due to intermittent noise on ECG and/or Respiration waveforms associated with the 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 recall affects 47,125 units distributed worldwide, including 38,710 in the United States and 8,415 outside the US. The devices are used in professional medical facilities such as emergency departments, operating rooms, and intensive care areas. Healthcare facilities should check their serial numbers against the recall list and contact GE Healthcare for instructions on corrective action.
The recalled product
- Product
- GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
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.
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