GE Patient Monitors May Display Inaccurate CO2 Readings at Non-Sea-Level Locations
GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.
What this means for you
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: This is a Class II FDA recall affecting patient monitors with a measurement inaccuracy issue specific to certain unit selections and non-sea-level locations. No illnesses or injuries have been reported, and the hazard is narrowly scoped, making this a precautionary recall.
Plain-English summary
GE Medical Systems, LLC is recalling certain B105P patient monitors with E-module slot option because they may display inaccurate CO2 measurements when used in locations not at or near sea level. The inaccuracy occurs when the monitor is set to display CO2 values using millimeters of mercury (mmHg) or kilopascals (kPa) as the unit of measurement.
Approximately 826 devices have been affected by this issue and have been distributed worldwide. Healthcare facilities and users of these monitors in locations at different elevations from sea level should verify their altitude and ensure proper operation of the device.
No injuries or illnesses have been reported to date in connection with this issue. Users are advised to contact GE Healthcare for guidance on correcting the measurement display, checking calibration settings, or obtaining information about device replacement options.
The recalled product
- Product
- B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
- co2-measurement-inaccuracy
- altitude-dependent-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00840682147217: Model Number 6160000-001-100174
- Serial Numbers: SR422332028WA
- SR422332025WA
- SR422332026WA
- SR422332027WA
- SR422332029WA
- SR422332030WA
- SR422332031WA
- SR422332032WA
- SR422332049WA
- SR422332050WA
- SR422332051WA
- SR422332052WA
- SR422332053WA
- SR422332054WA
- SR422332055WA
- SR422332056WA
- SR422332057WA
- SR422332061WA
- SR422332058WA
Distribution
Distribution scope not specified by the agency.
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