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SERVO-I Ventilator System - CO2 Analyzer (2015-02-09)
- Starting date:
- February 9, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43835
Recalled Products
- SERVO-I Ventilator System - CO2 Analyzer
Reason
The affected CO2 analyzer modules may experience a problem at the end of the calibration of the Capnostat 3 Sensor, causing the calibration to fail and activate the medium priority alarm "CO2 module error" on the user interface of the Servo Ventilator. This issue only affects the optional CO2 analyzer functionality, preventing it from displaying any measured CO2 values. It has no effect on any other functionality of the ventilator.
Affected products
A. SERVO-I Ventilator System - CO2 Analyzer
Lot or serial number
More than 10 lots, please contact the manufacturer.
Model or catalog number
- 65 23 588 E407E
Companies
- Manufacturer
-
Maquet Critical Care AB
Rontgenvagen 2
Solna