GE Healthcare Recalls Dash 3000 Patient Monitoring Systems
GE Healthcare is recalling Dash 3000 patient monitors because they may restart simultaneously during prolonged network overloads.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes the hazard as a simultaneous restart 'as designed' during network overload, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GE Healthcare, LLC is recalling approximately 182,640 Dash 3000, 4000, and 5000 patient monitoring systems. These devices are used to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
The recall is due to a software issue where the monitors may simultaneously restart if they are connected to the same network and a network overload occurs for a prolonged time. This behavior is described as restarting "as designed" in the source text.
The affected units were distributed nationwide, including Puerto Rico, Guam, and Samoa, as well as to government and military facilities. Foreign distribution included numerous countries across the globe. Users should contact GE Healthcare for instructions on how to address this issue.
The recalled product
- Product
- Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
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
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.
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