| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00003-1 |
| Product Name/Description |
Flow Anesthesia System - Flow-c, Flow-e and Flow-i
Article numbers: 6677200, 6677300, 6677400, 6888520, 6888530, 6888540, 6887700 & 6887900
Software versions: 04.08.00, 04.08.01, 04.08.02 or 04.08.03
ARTG 180464
(Getinge Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/01/2023 |
| Responsible Entity |
|
| Reason/Issue |
Getinge Australia are informing customers that in certain cases it has been reported that when the “High Continuous pressure” alarm has been triggered and at the same time the user switches to manual mode with the alarm still active, the safety valve stay open even after the “High Continuous pressure” is below the trigger point. The pressure cannot be built up, resulting in no ventilation.
Investigation has shown that same situation will occur if user ends the case/goes to stand-by with the “High Continuous pressure” alarm active.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge Australia are notifying customers that a Getinge authorised service personnel will visit their site to install SW 04.08.04 or higher. Users are asked to maintain an awareness on this issue whilst they wait for further communication from Getinge.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 438 464 - Customer Service. |