| TGA Action ID |
RC-2025-RN-00807-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
C1/C3/C6/MR1/T1 OXYGEN SENSOR
Product Code: HMT-396200
Vender Part: 396200
Serial Numbers: Z53XXXX – Z55XXXX |
| ARTG Number |
141159 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
When a new oxygen sensor is installed into Hamilton Medical ventilator (e.g., HAMILTON-C1/T1/MR1/C2/C3/C6), a communication error can prevent the ventilator from recognizing the oxygen sensor. In this case the ventilator will display a “Replace O2 sensor” alarm upon restart. The problem can be resolved by installing a new oxygen sensor.
Should no replacement oxygen sensor be available, the Hamilton Medical ventilator shall not be used until the oxygen sensor is replaced and the new oxygen sensor is working properly.
This behaviour is detected during the ventilator's self-test and does not occur during active ventilation. The only risk associated with this problem is unavailability of a ventilator in case a replacement oxygen sensor is not available. |
| Instructions for Customers/Users |
Inspect stock and identify stock of PN 396200 from the affected serial number range Z53XXXX until Z55XXXX on hand.
Oxygen sensors from the affected serial number range may be used (also to replace another oxygen sensor) provided that no alarm “Replace O2 sensor” is displayed. Therefore, please comply with the following instructions:
a) Affected oxygen sensor already in use: If no “Replace O2 sensor” alarm is displayed, the oxygen sensors with the serial number mentioned above can continue to be used. Hence, an oxygen sensor does not need to be changed just because it belongs to the affected serial numbers range.
b) Replacement of oxygen sensor with a new one from the affected serial number range (No “Replace O2 sensor” alarm displayed): If a used oxygen sensor is replaced with a new one that falls within the affected serial number range, and no “Replace O2 sensor” alarm appears after the replacement, the new sensor can be used without any restrictions. This means the sensor is considered safe to use as long as the alarm does not show up after restarting the system.
c) Replacement of oxygen sensor with a new one from the affected serial number range (“Replace O2 sensor” alarm displayed): If the “Replace O2 sensor” alarm appears after installing a new oxygen sensor from the affected serial number range, the sensor must be replaced again with another new one. If the alarm no longer appears after the second replacement, the ventilator can be used safely.
This action has been closed out on 05/01/2026 |
| Action Commencement Date |
22/09/2025 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies Australia |