| TGA Action ID |
RC-2026-RN-00433-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Intensive Care Ventilators elisa 300, elisa 500, elisa 600, elisa 600 R-VIT, elisa 800, elisa 800 R-VIT, elisa 800VIT and elisa 800 VIT RO
Software Versions: 1.x.x to 1.11.3, 2.02.x / 2.04.x to 2.04.8, 2.05.x / 2.06.x / 2.07.x / 2.08.x / 2.09.x to 2.09.16, 2.10.x to 2.10.9, 2.13.x to 2.13.9, 2.16.x to 2.16.4, 2.18.0 |
| ARTG Number |
477486 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Internal audits identified that, in some cases, a patient disconnection may not be detected during ventilation when PEEP is set to OFF / PEEP = 0 mbar.
The problem is related to the current design of the disconnection detection system. Ventilation with PEEP = 0 is typically used only in exceptional cases; however, because this setting is available, action is required to prevent the risk of an undetected disconnection to prevent the risk of an undetected disconnection.
There are currently no known reports of this problem occurring in clinical practice.
Updated 22/7/2026: Internal audits have revealed that, in some cases, a disconnection goes undetected during ventilation with low PEEP settings (PEEP < 2 mbar). This is due to the current design of the disconnection detection system. Ventilation with PEEP < 2 mbar is not representative of standard ongoing intensive ventilation but may occur in selected clinical situations, including weaning or spontaneous breathing trials. |
| Instructions for Customers/Users |
Customers should:
· Note that Updates for the affected software will be provided until October 1, 2026.
· Updating all elisa intensive care ventilators with the affected software version is mandatory.
· Operators and users may continue to use the ventilators. However, it is essential to ensure that a PEEP value greater than 0 is always set during ventilation. A PEEP value of at least 0.5 mbar ensures reliable detection of a disconnection.
· Please identify the customers to whom the affected devices were shipped.
· The necessary updates to the devices must be completed by March 31, 2027, at the latest.
Update 22/7/2026: It is essential to ensure that a PEEP value equal to or greater than 2 mbar is always set during ventilation and the patient is clinically monitored. A PEEP value of at least 2 mbar ensures reliable detection of a disconnection. |
| Action Commencement Date |
15/06/2026 |
| Responsible Entity |
|
| Contact Information |
SupportMD@loewensteinmedical.com - Lowenstein Medical Australia |