| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00406-1 |
| Product Name/Description |
O-Two Equinox Relieve and Equinox Advantage Analgesic Gas Delivery Systems
Multiple Serial Numbers
ARTG Number: 222055
(Gascon Systems - Analgesia unit, inhalation)
ARTG Number: 225844
(Mediquip Pty Ltd - Analgesia unit, inhalation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/05/2018 |
| 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.
Mediquip have been made aware by the manufacturer, O-Two Technologies, of reports where O2/N2O mixers have delivered higher doses of nitrous oxide than specification during routine testing. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Gascon 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. |
| Contact Information |
03 9499 4100 - Gascon Systems |