| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00355-1 |
| Product Name/Description |
V-Sign Sensor
Serial numbers: 315.592, 315.593, 315.595 & 315.596 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Based on high customer complaint rates SenTec has identified three production batches of V-Sign Sensors where the PCO2-measuring element shows signs of pre-mature aging; in some cases already after 4 to 11.5 months of use resulting in loss of PCO2-monitoring function.
This action was undertaken prior to notifying TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Temple Helathcare (local SenTec distributor) is contacting all the affected customers and replacing the sensor free of charge in return for the affected sensor. This action has been closed-out on 15/02/2016. |
| Contact Information |
Temple Heathcare - 02 4858 0690 |