| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01485-1 |
| Product Name/Description |
Equinox Advantage
O-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System
Multiple Serial Numbers
ARTG 225844 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, O-Two Medical Technologies has been made aware of an incident with one of the Equinox O2/N2O mixers where the oxygen supply of the reported mixer was cut off due to a disengaged piston seat in the equaliser that allowed 100% supply of nitrous oxide to be delivered to a patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mediquip will be contacting customers directly to plan the removal and upgrade of affected units. Loan units will be provided while customer units are being upgraded. In the interim, users are advised to refer to the updated IFU provided with the Customer Letter to use the device with an oxygen analyser.
This action has been closed out on 21/04/2021 |
| Contact Information |
1300 246 349 - Mediquip |