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SenTec Digital Monitoring System (SDMS)
- Starting date:
- November 5, 2012
- Posting date:
- November 5, 2012
- 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-16853
Recalled Products
- SenTec Digital Monitoring System (SDMS)
Reason
Due to a manufacturing defect that occurred for certain inserts, the new electrolyte cannot be expelled due to the fact that the hole for expelling the electrolyte is closed. If a membrane changer with the defective insert is used to change the membrane, as a consequence the sensor will be remembraned without electrolyte. The PC02 Sensor performance will be deteriorated without the presence of electrolyte, giving unstable or questionable results.
Affected products
A. SenTec Digital Monitoring System (SDMS)
Lot or serial number
1D58, 1D80
Model or catalog number
VS-MCI
Companies
- Manufacturer
- Sentec AG