| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00107-1 |
| Product Name/Description |
Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01
Model Numbers: 100 and 202
ARTG Numbers: 159490 and 174169 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips Respironics has become aware that Trilogy Ventilators with the affected software versions and dual therapy prescriptions are susceptible to an inadvertent change between prescriptions. This may occur under a particular set of operating conditions without requiring confirmation of the change by the user.
- Device connected to the AC power source
- Device software versions 13.2.04, 13.2.05, 14.0.0 or 14.1.01
- Dual prescription is ON
- Menu Access is LIMITED
- Device powered ON
- The device is allowed to operate for 5 or more minutes without pressing the UP arrow key
Pressing the right key selects the “Switch to Secondary Settings” menu. Pressing the Right key again within the next 30 seconds, confirms the “Switch to Secondary Settings” and the device will switch from the Primary to the Secondary Settings. The devices continue to display the active prescription in the upper left hand corner of the display, however, the user may be unaware of this change. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users that there is a software update available (my.respironics.com) for users to upgrade the device software to version 14.1.02. This action has been closed out 01 Feb 2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |