GE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues
GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a functional interruption (restart) dependent on specific network conditions, with no reported injuries or deaths.
Plain-English summary
GE Healthcare Finland Oy is recalling approximately 59,000 units of the CARESCAPE Monitor B450. This multi-parameter patient monitor is intended for use in professional healthcare facilities for monitoring adult, pediatric, and neonatal patients. The units were distributed worldwide and across the United States.
The recall is due to a software issue where multiple CARESCAPE Monitor B450 or B850 units connected to the same network may simultaneously restart if a network overload occurs for a prolonged time. The monitor restart process will not be completed until the network issue is corrected, which could result in a loss of monitoring data or functionality during the restart period.
Healthcare facilities should check their inventory for affected serial numbers listed in the recall notice. If a unit is affected, facilities should follow the instructions provided by GE Healthcare for remediation or replacement to ensure continuous patient monitoring.
The recalled product
- Product
- GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional…
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient Monitor
- Affected units
- 59,000
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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