| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00126-1 |
| Product Name/Description |
Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & IntelliSave AX700
Siesta i Breasy
Product Numbers: 866204/10652-00
Siesta i Whispa
Product Numbers: 866202/10651-00
Dameca MRI 508
Product Numbers: 866203/10651MRI-00
Siesta i TS
Product Numbers: 866163/10653-00
IntelliSave AX700
Product Numbers: 866205/10623-00
Multiple Serial Numbers affected
ARTG Number: 176848 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function. It can be brought up to working condition again by simply pulling it out. The control dial is part of the user interface and serves an important role in setting and controlling the anaesthesia machine functions as it is used to adjust and confirm settings made by the user.
For Siesta i Breasy, Siesta i Whispa and MRI 508 freshgas regulation and ventilator mode change (Manual or Ventilator) can still be done as this is mechanical and/or soft key controlled and doesn’t need confirmation by the control dial.
For Siesta i TS and IntelliSave AX700 it is not possible to regulate freshgas delivery or change ventilator mode as this needs confirmation by the control dial.
For all machine types ventilation will continue at the previously set parameters |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is requesting all its customers to check their machines for the faulty control dial and is replacing control dials on devices exhibiting the issue. End users are provided work around instructions to assist in the continued use of affected units. The anesthesia machine can continue to be used as the control dial can be pulled out, making the control dial work. This action has been closed-out on 08/08/2016. |
| Contact Information |
02 9975 5755 - Device Technologies Australia |