| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00555-1 |
| Product Name/Description |
Neptune 2 Rovers
(Mobile unit used as surgical fluid/smoke waste management system)
Catalogue Number: 0702-001-000
Serial Numbers ranging from 0803118093 through 505400223
Distribution or Repair Dates: 1 Nov 2011 to 31 Mar 2015
ARTG Number: 164275 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
30/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified during the installation of Neptune Rovers that there is a potential for the Rover’s Diverter Valve Assembly to not actuate during docking, preventing the cleaning cycle from occurring and inhibiting prefill water from being supplied to the Neptune Fresh Water System. The Diverter Valve’s material combined with the heat-treating process has the potential to cause diverter valve corrosion when the Rover is allowed to sit for a period of greater than 40 days.
Only Neptune 2 Rovers out of rotation for greater than 40 days have the potential of exhibiting the failure.
There is no risk to health as the Neptune Rover will be unable to dock either during installation or prior to surgery. Rovers that are in active rotation are not likely to experience any issue related to this diverter valve material issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Stryker Representative will contact affected facilities who have indicated they have Rovers which have not been used for over 40 days to schedule time to perform the diverter valve replacement. This action has been closed-out on 03/03/2016. |
| Contact Information |
02 9467 1087 - Stryker |