The Recall Desk
HighFDA (Devices)·Z-0731-2023·Announced 2022-12-28

GE B105M Patient Monitor displays inaccurate CO2 readings at altitude

GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.

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 potential measurement inaccuracy in patient monitoring equipment. No injuries or illnesses have been reported, but this represents a risk-of-harm situation where inaccurate CO2 readings could impact clinical care.

Plain-English summary

GE Healthcare has identified a defect in certain B105M patient monitors (REF 6160000-003) affecting approximately 3,905 units with worldwide distribution. When these monitors are configured to display CO2 measurements using mmHg or kPa units, the displayed CO2 value can be inaccurate if the equipment is operated at locations that are not at or near sea level.

Affected facilities and healthcare providers should verify their monitor model numbers and serial numbers against the FDA recall notice to determine if their equipment is included in this recall.

The recalled product

Product
B105M Patient Monitor, REF 6160000-003
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Patient Monitoring Equipment
Hazard
Affected units
3,905

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 00840682146708: Model Number 6160000-003
  • Serial Numbers: SR622160009SA
  • SR622160008SA
  • SR622092012WA
  • SR622092005WA
  • SR622092028WA
  • SR622092001WA
  • SR622092007WA
  • SR622092027WA
  • SR622092010WA
  • SR622092024WA
  • SR622092022WA
  • SR622092006WA
  • SR622092020WA
  • SR622092030WA
  • SR622092013WA
  • SR622092019WA
  • SR622092009WA
  • SR622092016WA
  • SR622092018WA

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 · measurement inaccuracy

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