| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00100-1 |
| Product Name/Description |
Mako RIO System Ethernet to Fiber Optic Converter
Item Number: 200933
All Lot Numbers
ARTG Number: 223105
(Stryker Australia Pty Ltd - Robot, surgical, navigation unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has discovered that certain Ethernet to Fibre Optic Converters did not pass testing due to a RIO Connection error. A RIO Connection error will occur when communication is lost between the RIO and the Guidance Module. In the event a Mako System experiences a RIO Connection error, a network connection error message will appear on the system display |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Stryker will arrange replacement of all Ethernet to Fibre Optic Converters of affected units with updated converters.
This action has been closed out on the 08/11/2018. |
| Contact Information |
02 9467 1175 - Customer Service Support |