GE Healthcare Recalls Solar 8000M Patient Monitoring Systems
GE Healthcare is recalling Solar 8000M patient monitors because they may restart simultaneously during network overload, potentially disrupting patient monitoring.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (patient monitoring) where injury has not yet been reported, fitting the 'High' severity criteria.
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 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.
The affected monitors 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. The recall classification is Class II, indicating that use of the product could create a temporary or medically reversible health risk.
Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. Patients and caregivers should consult with their healthcare providers regarding the safety of their monitoring equipment.
The recalled product
- Product
- Solar 8000M 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
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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