GE Healthcare CARESCAPE Monitor B850 Recalled for Network-Related Restart Issues
GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.
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. The hazard involves a functional interruption (simultaneous restart) during network overload, which is a significant operational issue but does not involve reported injuries, deaths, or immediate physical harm mechanisms like fire or shock.
Plain-English summary
GE Healthcare Finland Oy is recalling 47,937 units of the CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor used in professional healthcare facilities. The recall is due to a software behavior where, if multiple B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed.
The monitor restart process will not be completed until the underlying network issue has been corrected. This recall covers units distributed worldwide and within the United States. The affected serial numbers are listed in the official recall notice.
Healthcare facilities should check their inventory against the provided list of serial numbers. If a unit is affected, the facility should follow the instructions provided by GE Healthcare to address the network configuration or apply any necessary software updates to prevent simultaneous restarts during network overloads.
The recalled product
- Product
- GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare…
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient Monitor
- Affected units
- 47,937
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare Finland Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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