| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00953-1 |
| Product Name/Description |
Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia Machines
Manufactured from 23 April 2013 to 22 July 2013
Multiple serial numbers affected
ARTG Number: 93955 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrom ventilator and the Aespire View, Aisys and Avance anaesthesia machines. As a result of a manufacturing issue, the buttons on the left, right and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected. If a button has no response, the menu function may be accessible through the use of the control wheel. If none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative. GE Healthcare will correct all affected systems. |
| Contact Information |
1800 659 465 - GE National Call Centre |