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Sentec Digital Monitor System - V-Sign Sensor 2 (2015-04-17)
- Starting date:
- April 17, 2015
- Posting date:
- June 1, 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-53553
Recalled Products
- Sentec Digital Monitor System - V-Sign Sensor 2
Reason
The PCO2 performance does not comply with Sentec's quality standards for customer satisfaction. Therefore, this recall is for the return and replacement of impacted device(s). Sentec's risk evaluation concludes no adverse safety impact for patient or user.
Affected products
A. Sentec Digital Monitor System - V-Sign Sensor 2
Lot or serial number
- S/N: 315.124
- S/N: 315.124
- S/N: 315.284
- S/N: 315.284
Model or catalog number
- VS-A/P/N
- VS-A/P/N
Companies
- Manufacturer
-
SenTec AG
Ringstrasse 39, Therwil,
Basel land
4106
SWITZERLAND