GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
GE Healthcare is recalling CARESCAPE Monitor B650 and B850 units due to potential safety issues with Non-Invasive Blood Pressure and Bed to Bed functions.
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. Per the rubric, Class II recalls without explicit reports of hospitalization or death fall into the High severity category, representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 676 units of CARESCAPE Monitor B650 and CARESCAPE Monitor B850 patient monitors. These multi-parameter monitors are intended for use in professional healthcare facilities to monitor hemodynamic, respiratory, and neurophysiological parameters for adult, pediatric, and neonatal patients.
The recall was initiated because GE Healthcare became aware of potential safety issues associated with these devices. Specifically, the issues involve the Non-Invasive Blood Pressure (NIBP) function and the Bed to Bed functionality. The affected units were distributed nationwide in the United States and internationally to several countries in Europe, including Austria, Belgium, the Czech Republic, Finland, France, Germany, Greece, Italy, Lithuania, Poland, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact GE Healthcare for instructions on how to resolve the safety issues. No specific injuries or illnesses are reported in the source text.
The recalled product
- Product
- GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 676
Distribution
Distributed nationwide across the United States.
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