| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00174-1 |
| Product Name/Description |
Getinge 46-Series Washer Disinfector with PACS 300/350
ARTG Number: 125655 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received complaints in Germany regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control.
The potential risk is that during the drying phase the air circulating may transport particles from the sedimentation and deposit it on goods. If the particle contains bacterial flora there is the risk of cross contamination.
The problem has been identified as insufficient water flow throughout the manifold due to formation of air-pockets where sedimentation may occur. The use of detergents that are not recommended might also have negative impact.
No serious injury has been reported in any of the known cases. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getinge will contact customers to carry out a modification that will permanently mitigate the risk of this issue occurring in the future. In the interim customers are advised to perform a visual check of all washed items after removal from the washer. Items should be re-washed if any particles are observed. This action has been closed-out on 1/06/2016. |
| Contact Information |
1300 155 500 - Getinge Customer Service |