The Recall Desk
HighFDA (Devices)·Z-0494-2013·Announced 2012-12-26

GE Healthcare Recalls Dash Patient Monitors Due to NBP Cycling Issue

GE Healthcare is recalling 119,260 Dash 3000/4000/5000 patient monitors due to a potential issue where Custom Automatic NBP Measurement cycling may stop unexpectedly.

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, and the hazard involves a potential failure of a critical monitoring function (NBP cycling) in a medical device, which poses a risk of harm if injuries or illnesses have not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 119,260 units of the Dash 3000/4000/5000 patient monitors. 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 being conducted because GE Healthcare has become aware of a potential issue involving an unexpected loss of Custom Automatic NBP (Non-Invasive Blood Pressure) Measurement cycling. This defect could affect the monitor's ability to automatically cycle through blood pressure measurements as configured.

The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and users should contact GE Healthcare for further instructions on how to address this issue.

The recalled product

Product
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients
Manufacturer
GE Healthcare, LLC
Affected units
119,260

Distribution

Distributed nationwide across the United States.