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Single Width Airway Module(2014-05-21)
- Starting date:
- May 21, 2014
- Posting date:
- June 5, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39821
Recalled Products
Single Width Airway Module
Reason
GE has found that there can be a failure of the CO2 detector in the single-width airway and extension modules. Failure of the CO2 detector in single-width airway and extension modules may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect et CO2/FiCO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values.
Affected products
Single Width Airway Module
Lot or serial number
Not applicable
Model or catalog number
E-MINIC-00
E-MINIC-00-EN
Companies
- Manufacturer
-
GE Healthcare Finland OY
Kuortaneenkatu 2,
Helsinki
00510
FINLAND