GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
GE Healthcare is recalling CARESCAPE B650 and B850 monitors due to 25 reported safety issues involving alarms and connectivity.
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 involves a medical device with reported safety issues affecting patient monitoring functions (NIBP, ECG), which poses a risk of harm, but the source does not explicitly report injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling the CARESCAPE Monitor B650 and CARESCAPE Monitor B850. These are multi-parameter patient monitors used in professional healthcare facilities to monitor vital signs such as blood pressure, ECG, and respiration.
The recall was initiated because GE Healthcare became aware of 25 potential safety issues associated with these devices. The reported issues involved Non-Invasive Blood Pressure (NIBP) alarms, ECG, Central Monitor, General, Tram, and Bed to Bed functions.
A total of 40,239 units are affected, with 17,182 units in the United States and 23,147 units outside the US. The devices were distributed nationwide in the US (excluding Delaware, South Dakota, North Dakota, and Vermont) and in numerous countries internationally. Healthcare facilities should contact GE Healthcare for further instructions on how to address these safety issues.
The recalled product
- Product
- GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. 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 CARESCAPE Monitor B650 is intended…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
Distribution
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