| TGA Action ID |
RC-2026-RN-00184-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Neonatal heat therapy devices
Lifetherm 2000 heated bed, height-adjustable
Item Number: 0215000hul200
Lifetherm 2002 resuscitation unit
Item Number: 0216001hul300
Lifetherm 2003 resuscitation unit
Item Number: 0216002hul300 |
| ARTG Number |
293363 |
| Unique Device Identifier (UDI) |
(01)04260171271197(11)251200(21)0215000hul99945719 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer has identified that the display board (Part No. 0210026v01) installed in certain Lifetherm neonatal heat therapy devices may have been incorrectly assembled during production.
As a result, the device may experience a potential malfunction of the display after an undefined period of operation. In the event of damage, the component could also potentially lead to overheating and smoke development.
No incidents or device failures have been reported to date.
This market action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
Customers are to replace affected display boards with replacement stock supplied by Loewenstein Medical Technology.
This action has been closed out on 13/04/2026 |
| Action Commencement Date |
17/03/2026 |
| Responsible Entity |
|
| Contact Information |
vigilace.au@loewensteinmedical.com - Loewenstein Medical Technology |