| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00146-1 |
| Product Name/Description |
ED-530TK Duodenoscope
Serial Numbers: MD102A129, MD102A130, 1D102K227, 1D102K388, 1D102K394, 1D102K436, 1D102K460, D102K508, 1D102K517
ARTG Number: 139172
(Fujifilm Australia - Duodenoscope, flexible, video - Dudoenoscope, flexible, video) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
In response to recent concerns regarding the ability to thoroughly clean duodenoscopes, FUJIFILM has redesigned some components of the ED-530XT duodenoscope.
Corrective actions for the ED-530XT include replacement of the forceps elevator mechanism and O-ring seal, replacement of the distal end cap, and new Operation Manual. The updated design, maintenance schedule and labelling have all been implemented to help reduce any potential risk to health that may be associated with inadequate reprocessing of the device.
FUJIFILM, through the distributor C.R. Kennedy & Co, will provide a revised operation manual to be followed.
Below is the main update to the operation manual:
- Added the requirement for the ED-530XT to be returned to local FUJIFILM dealer or authorised service representative for inspection and replacement of the forceps elevator seal once a year to maintain safe use of the device. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
FujiFilm is advising users to review and update the handling and re-processing procedures.
Affected products will be serviced to replace the affected parts.
This action has been closed out on the 22/11/2018. |
| Contact Information |
02 9466 2600 - FujiFilm Australia |