| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00560-1 |
| Product Name/Description |
Maxi Air Blower Unit - Model 230V
(a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)
Serial Numbers: S0112300, S0112299, S0102544
ARTG Number: 215885 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The plastic enclosure used in the Maxi Air supply motor for models 230V is not fire retardant. This can be seen by the "arrows" on the moulded part and was confirmed by an ad-hoc flammability test. This may increase the risk of a fire spreading. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
An ArjoHuntleigh representative will attend the affected hospital to replace the affected blower unit.
This action has been closed out on 02/11/2018 |
| Contact Information |
08 9314 4117 - ArjoHuntleigh |