| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01216-1 |
| Product Name/Description |
Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)
Model Number: 01280010
Serial Numbers: 4H120383, 4H120384
ARTG Number: 228574 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware that due to a software issue, if the compressed air supply of the machine is lost right before or during product supply (DLC detergent, Aperlan Poka-Yoke Agent A/B disinfectant), and after cycle start, and not re-established before cycle end, the machine does not launch or complete the product supply when reprocessing a scope. As a result, no alarm is triggered. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getinge is advising users of interim instructions to follow. Users are advised to carefully examine the printer ticket at the end of each reprocessing cycle to ensure there are 3 lines printed for DLC weight, Disinfectant A and B weights are OK. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 20/02/2017. |
| Contact Information |
1300 155 500 - Getinge Australia |