Agency classClass IIOur severity:High FDA (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.

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: 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: co2-measurement-inaccuracy
altitude-dependent
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 →

Same manufacturer · GE Medical Systems, LLC

See all →

High
Mobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
High
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
High
GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
High
Giraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
High
Giraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24

Same hazard · co2 measurement inaccuracy