| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00906-1 |
| Product Name/Description |
GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor
Model Numbers:
01039717 – Right hinge EDS8-R and
01039716 – Left hinge EDS8-L
ARTG Number: 276061
(Getinge Australia Pty Ltd - Endoscope drying/storage chamber) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge have identified an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the EDS8.
This potential for malfunction is caused by a device design issue. It is identified that the delivered pressure and flow rate of the EDS8 compressor is too low. Under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5L/min airflow required to properly dry/store the endoscopes.
Getinge have received several complaints related to this issue, but there was no reported user or patient injury. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.
This action has been closed out on 15/08/2019 |
| Contact Information |
1800 438 464 - Getinge Customer Service |