GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure
GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.
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 monitoring device failure that poses a risk of harm to patients, although no injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling the Solar 8000M and Solar 8000i Patient Monitor software versions 5.4, 5.5, and 5.6 when the Automatic-View-On-Alarm (AVOA) feature is enabled. The recall involves 10,211 units distributed worldwide, including 7,549 units in the United States and 2,662 units outside the US.
The recall is due to a potential safety issue where the AVOA feature stops functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed. Once this issue occurs, subsequent remote AVOA functionality is affected. The source text does not report any illnesses, injuries, or deaths associated with this defect.
These devices are intended for use in professional medical facilities such as hospitals, clinics, and surgical centers for monitoring adult, pediatric, and neonatal patients. Healthcare facilities should contact GE Healthcare for instructions on how to address the software issue.
The recalled product
- Product
- GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
Distribution
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