Agency classClass IIOur severity:High FDA (Devices)·Z-0733-2023·Announced 2022-12-28

GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Altitude

GE Healthcare is recalling B125M patient monitors because the CO2 measurement display can be inaccurate at locations above sea level when configured for mmHg or kPa units.

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 of a patient monitoring device. The CO2 measurement defect creates a risk of inaccurate readings that could affect clinical decisions, but no injuries or illnesses have been reported. This meets the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Healthcare is recalling B125M patient monitors due to a defect in CO2 measurement accuracy. The displayed CO2 values can be inaccurate when these monitors are used at locations that are not at or near sea level and are configured to display CO2 in millimeters of mercury (mmHg) or kilopascals (kPa). Approximately 3,348 units have been distributed worldwide.

Healthcare facilities should identify B125M monitors in their inventory and verify the serial numbers against the recall information provided by GE Healthcare.

Users of affected B125M monitors are advised to contact GE Healthcare for guidance. No illnesses or injuries have been reported in connection with this defect.

The recalled product

Product: B125M Patient Monitor, REF 6160000-005-XXXXXXX
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Patient Monitoring
Hazard: co2-measurement-inaccuracy
altitude-dependent-error
Affected units: 3,348

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 00840682146791: Model Number 6160000-005
Serial Numbers: SR821512013WA
SR821512014WA
SR821512017WA
SR821512016WA
SR821512015WA
SR821430047WA
SR821430049WA
SR821430048WA
SR821430050WA
SR821410068WA
SR821170021WA
SR822062011WA
SR821260059WA
SR822072018WA
SR822072016WA
SR822072015WA
SR822072022WA
SR822072021WA
SR822072020WA

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

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