GE Healthcare Recalls Carestation Monitors for Potential Malfunction
GE Healthcare is recalling Carestation 620, 650, and 650c monitors due to potential for elevated FiCO2 readings and unexpected system malfunctions.
What this means for you
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 potential system malfunction and inaccurate readings in a medical device, which poses a risk of harm to patients, but no specific injuries or deaths are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 patient monitors. The recall involves 3,448 units, with 334 units distributed in the United States and 3,114 units distributed outside the US.
The FDA has classified this as a Class II recall. The devices have a potential for elevated FiCO2 (fraction of inspired carbon dioxide) readings and unexpected system malfunctions. These issues could affect the accuracy of patient monitoring and the reliability of the device during use.
Healthcare facilities and users should contact GE Healthcare for instructions on how to address the defect. The recall covers units distributed across numerous US states and territories, as well as many international locations.
The recalled product
- Product
- Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
Distribution
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