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.
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 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
- Category
- Medical Device — Patient Monitor
Distribution
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