GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise
GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection 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. The hazard involves reduced performance of a medical monitoring device (ECG/arrhythmia detection) without reported injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling the Dash 3000, Dash 4000, and Dash 5000 patient monitoring systems. These devices are intended to monitor physiologic parameter data on adult, pediatric, and neonatal patients. The recall involves approximately 28,120 units distributed worldwide, including the United States and numerous international markets.
The recall is due to a potential safety issue where movement of the ECG connector on the DASH, PDM, and/or Tram Module can cause intermittent noise on ECG and/or Respiration waveforms. This signal noise may result in reduced performance for ECG, Respiration, and arrhythmia detection. The source text does not report any specific injuries, illnesses, or deaths associated with this issue.
Healthcare facilities and consumers should check their device serial numbers against the list provided in the official recall notice. If a device is affected, users should contact GE Healthcare for instructions on corrective action, which may include software updates or hardware modifications to mitigate the signal noise.
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.
- 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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