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Compact Airway Module (2014-04-21)
- Starting date:
- April 21, 2014
- Posting date:
- May 6, 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-39341
Recalled products
- Compact Airway Module
Reason
Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airwway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either "low gas sample flow" or "check sample gas out".
Affected products
A. Compact Airway Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- E-CAIO-00-EN
- E-CAIO-00-FR
- E-CAIOV-00-EN
- E-CAIOV-00-FR
- E-CO-00-EN
- E-COV-00-FR
- E-COVX-00-EN
Companies
- Manufacturer
-
GE Healthcare Finland OY
Kuortaneenkatu 2,
Helsinki
00510
FINLAND