The Recall Desk
HighFDA (Devices)·Z-0982-2014·Announced 2014-02-26

GE Healthcare Recalls Dash Patient Monitors Due to Network and ECG Issues

GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors and Dash Port 2 Docking Stations due to network communication failures and distorted ECG waveforms.

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 involves a risk-of-harm product (patient monitor) where loss of monitoring and distorted ECG waveforms could lead to patient injury, but the source text does not report any specific injuries or illnesses.

Plain-English summary

GE Healthcare, LLC is recalling the Dash 3000, Dash 4000, and Dash 5000 Patient Monitors and the Dash Port 2 Docking Station. The recall involves 178,711 units distributed worldwide, including 92,123 units in the United States and 86,588 units internationally.

The recall is being conducted because the devices have been found to have multiple issues. Specifically, the Dash monitors may stop communicating on the Unity Network, which results in a loss of monitoring at the CARESCAPE CIC Pro Central Station. Additionally, the devices may display distorted ECG waveforms when in combination monitoring mode, and they may incorrectly become the Time Master on the Unity Network.

Healthcare facilities and consumers with these devices should contact GE Healthcare for further instructions on how to address these issues. The affected units are identified by specific serial numbers listed in the official recall documentation.

The recalled product

Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Manufacturer
GE Healthcare, LLC

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: