The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0524-2019·Announced 2018-12-05

GE Healthcare Recalls Solar 9500 Patient Monitors Due to Network Overload Risk

GE Healthcare is recalling approximately 3,864 Solar 9500 Information Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.

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: This is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for significant harm if monitoring is interrupted.

Plain-English summary

GE Healthcare, LLC is recalling approximately 3,864 Solar 9500 Information 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.

The affected monitors were distributed nationwide, including Puerto Rico, Guam, and Samoa, as well as to government and military entities. Foreign distribution included Canada and numerous other countries across multiple continents. The recall applies to all monitors of this model.

Healthcare facilities and consumers should contact GE Healthcare for instructions on how to address this issue. The source text does not specify specific actions for end-users beyond the general recall notice, but facilities should verify if their devices are affected and follow manufacturer guidance.

The recalled product

Product
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Patient Monitor
Hazard
Affected units
3,864

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 →

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