The Recall Desk
HighFDA (Devices)·Z-0520-2019·Announced 2018-12-05

GE Healthcare Recalls Dash 4000 Patient Monitoring Systems

GE Healthcare is recalling Dash 4000 Patient Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.

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 medical device where a network overload could cause simultaneous restarts, posing a risk of harm to patients due to loss of monitoring, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling approximately 182,640 Dash 4000 Patient Monitoring Systems. These devices are used to monitor physiologic parameter data on adult, pediatric, and neonatal patients.

The recall was initiated because the patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. This issue could affect the continuous monitoring of patients.

Distribution was made nationwide, including Puerto Rico, Guam, and Samoa, as well as to government and military facilities. Foreign distribution was made to numerous countries across the globe. Users should contact GE Healthcare for instructions on how to address this issue.

The recalled product

Product
Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Manufacturer
GE Healthcare, LLC

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All monitors

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 6 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.

See all 6 products in this recall →