The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0522-2019·Announced 2018-12-05

GE Healthcare Recalls Solar 8000i Patient Monitoring Systems

GE Healthcare is recalling approximately 73,673 Solar 8000i and 8000M patient monitoring systems because they may simultaneously restart 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 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 medical device with a risk of harm (simultaneous restart) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare, LLC is recalling approximately 73,673 Solar 8000i and 8000M patient monitoring systems. These devices are used to monitor physiologic parameter data on adult, pediatric, and neonatal patients. The recall was initiated because the 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 products 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 covers all monitors of the specified models.

Healthcare facilities should contact GE Healthcare for instructions on how to address the potential network overload issue. Consumers and patients should not use these devices if they are experiencing network connectivity issues that could trigger a simultaneous restart.

The recalled product

Product
Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Patient Monitoring
Hazard

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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