GE Healthcare Patient Monitors Recalled for Incorrect ECG Filter Settings
GE Healthcare is recalling specific patient monitors because they may apply an incorrect ECG filter setting if impedance respiration is enabled at startup.
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, and the hazard involves a risk-of-harm product (patient monitor) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling the Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 due to a potential safety issue with ECG filter settings. The recall affects 16,061 units distributed in the United States and internationally.
The issue occurs when the monitor starts with impedance respiration set to the ON position. In these cases, the device may apply an additional 0.5 Hz high pass filter instead of the user-selected filter. This incorrect setting could affect the display of ECG data.
Healthcare facilities should check their inventory for the affected serial numbers listed in the recall notice. Users should contact GE Healthcare for instructions on how to resolve the issue or replace the units.
The recalled product
- Product
- HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
Distribution
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