The Recall Desk
HighFDA (Devices)·Z-0732-2023·Announced 2022-12-28

GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Elevations

GE B125M patient monitors may display inaccurate CO2 measurements at high elevations when using mmHg or kPa units. Measurement accuracy can be affected in locations significantly above sea level.

What this means for you

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: This is an FDA Class II recall affecting a patient monitor used to display vital sign measurements. While no illnesses or injuries have been reported, the inaccuracy of a critical measurement parameter (CO2) at high elevations represents a risk of patient harm if incorrect readings influence clinical decisions, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The B125M is a patient monitor manufactured by GE Healthcare that displays vital signs including CO2 measurements. When using mmHg or kPa as the display unit for CO2 measurement, the monitor displays inaccurate values in locations at elevations significantly above sea level. The inaccuracy is specific to these unit selections and elevation conditions.

Approximately 5,962 B125M monitors with certain model numbers and serial numbers are affected worldwide. This is a Class II recall issued by the FDA.

Patients and healthcare facilities using these monitors in locations at high elevation should be aware that CO2 measurements displayed in mmHg or kPa units may be inaccurate. Changing the display unit away from mmHg or kPa may resolve the issue, or contact GE Healthcare for further guidance.

Healthcare providers should review this recall notice and determine if their facility's monitors are included in the affected serial number ranges provided by GE Healthcare.

The recalled product

Product
B125M Patient Monitor, REF 6160000-004-XXXXXX
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Patient Vital Signs Monitor
Hazard
Affected units
5,962

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 00840682146715: Model Number 6160000-004
  • Serial Numbers: SR722210034SA
  • SR722210037SA
  • SR722210030SA
  • SR722210040SA
  • SR722210042SA
  • SR722210039SA
  • SR722210041SA
  • SR722220001SA
  • SR722210029SA
  • SR722220004SA
  • SR722220005SA
  • SR722210031SA
  • SR722210032SA
  • SR722220002SA
  • SR722210035SA
  • SR722210038SA
  • SR722210033SA
  • SR722210028SA
  • SR722220003SA

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by GE Medical Systems, LLC 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.

See all 5 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · co2 measurement inaccuracy

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