| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00680-1 |
| Product Name/Description |
Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)
Multiple Lot Numbers affected.
ARTG Number: 145859 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has received a small number of reports where the pump may be supplied with the pump head in the unlocked position. If the pump head is unlocked, this may cause the pump to stop and go into stand-by mode. As a result, no water will be delivered to the endoscope. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus are requesting users to discontinue use of the affected devices. An Olympus Field Service Technician will perform an inspection and modification if required. Olympus is also providing inspection and modification instructions should the end user wish to correct the device.
At the time of agreement 17 customers had received the correction. These customers have been provided with the product correction information for their records. |
| Contact Information |
03 9265 5429 - Olympus Quality Assurance |