The Recall Desk
HighFDA (Devices)·Z-0730-2023·Announced 2022-12-28

GE B125P Patient Monitor CO2 Display May Show Inaccurate Readings at High Altitudes

GE is recalling B125P patient monitors because CO2 measurements may be inaccurate when used at non-sea-level altitudes in mmHg or kPa mode.

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 involving a patient monitoring device with a measurement accuracy defect affecting a critical care parameter. No hospitalizations or injuries have been reported. The hazard represents a risk-of-harm scenario where inaccurate CO2 readings could affect clinical decisions. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems is recalling B125P patient monitors (Model 6160000-002) distributed worldwide due to a measurement accuracy defect affecting 388 units.

The monitors may display inaccurate CO2 values when used at locations not at or near sea level and configured to display CO2 in mmHg or kPa units. Depending on clinical context, reliance on inaccurate CO2 readings could affect patient monitoring and clinical decision-making.

Healthcare facilities with affected devices should contact GE Medical Systems for guidance on corrective actions and device management.

The recalled product

Product
B125P Patient Monitor (with E-module slot option), REF 6160000-002
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Patient Monitor
Hazard
Affected units
388

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 00840682147224: Model Number 6160000-002-100174
  • Serial Numbers: SR522350004WA
  • SR522350001WA
  • SR522350002WA
  • SR522350003WA
  • SR522350005WA
  • SR522350006WA
  • SR522350007WA
  • SR522350008WA
  • SR522350009WA
  • SR522350010WA
  • SR522350011WA
  • SR522350012WA
  • SR522350013WA
  • SR522350014WA
  • SR522350015WA
  • SR522350016WA
  • SR522350017WA
  • SR522350018WA
  • SR522350019WA

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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