| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00845-1 |
| Product Name/Description |
Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)
Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)
ARTG Number: 140207 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers, resulting in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. A fresh gas leak in the vaporizer does not affect delivery of the set anaesthetic agent concentration but could result in a reduction in the volume of fresh gas delivered to the breathing system. This can lead to a reduction of flow of oxygen delivered to the patient, resulting in hypoxic gas concentrations and/or a reduction in the volume of anaesthetic agent delivered to the breathing circuit which may cause light anesthesia. The fresh gas leak may release Nitrous Oxide (N2O) gas into the ambient air and may result in clinician exposure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing users with an addendum with directions to perform the low pressure test with the dial turned to 12%. Users are advised by GE to discontinue use of vaporizors if it fails at 12%. If the vaporizer passes, the device can continue to be used. GE will be repairing/replacing the seals on all Tec 6 and Tec 6 Plus vaporizers as a permanent fix in August 2013. |
| Contact Information |
1800 659 465 - GE National Call Centre |