GE Healthcare CARESCAPE Monitor B650 Recalled for Network Overload Restart Issues
GE Healthcare is recalling 69,231 CARESCAPE Monitor B650 units worldwide because they may simultaneously restart during prolonged network overloads.
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, but the source text explicitly states no illnesses or injuries have been reported and the hazard is a functional interruption (restart) rather than a direct physical injury risk, fitting the 'Moderate' criteria for low-risk or theoretical hazards.
Plain-English summary
GE Healthcare Finland Oy is recalling 69,231 units of the CARESCAPE Monitor B650. The recall is due to a defect where multiple monitors connected to the same network may simultaneously restart if a network overload occurs for a prolonged time. The monitors are designed to restart in this scenario, but the restart process will not be completed until the underlying network issue is corrected.
The affected units were distributed worldwide. The recall notice lists specific serial numbers for the affected devices. No illnesses or injuries have been reported in the source text.
Healthcare facilities should check their inventory against the provided serial number list. If a unit is affected, the manufacturer will provide instructions for correcting the network issue or replacing the device to ensure the monitor restarts properly.
The recalled product
- Product
- GE Healthcare CARESCAPE Monitor B650
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient Monitor
- Affected units
- 69,231
Distribution
Distribution scope not specified by the agency.
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