GE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues
GE Healthcare is recalling 12,779 CARESCAPE Monitor B850 units due to four potential issues, including uDOM failure, unstable USB communication, remote printing errors, and reboots caused by an X server freeze.
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, and the source text describes potential software and hardware issues without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare, LLC is recalling 12,779 units of the CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor used in professional healthcare facilities. The recall is due to four potential issues identified by the manufacturer: uDOM failure, unstable USB communication, a remote printing issue with the currently printing PRN 50 recorder, and reboots caused by an X server freeze.
The affected monitors are intended for use on adult, pediatric, and neonatal patients in various clinical settings. The recall covers units distributed worldwide, including nationwide distribution in the United States and in numerous international countries.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. GE Healthcare is the recalling firm and is responsible for addressing these issues. No specific consumer actions are detailed in the source text beyond the identification of the affected units.
The recalled product
- Product
- CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 12,779
Distribution
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