| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00312-1 |
| Product Name/Description |
da Vinci Si and Xi Surgical System - Touchpad Compact Flashcards
da Vinci Si/Xi SSC Touchpad
Part Number:187505-04
da Vinci Xi PSC Touchpad
Part Number: 187716-03
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive Surgical has found that compact flash cards used in touchpads on specific da Vinci Si and Xi Surgical Systems to save user preferences, have the potential to become corrupted when the touchpads experience an abrupt power loss and/or are powered on and off within a short period of time.
The corruption of the compact flash occurs when power is cycled. If the compact flash has been corrupted, the da Vinci system will display a fault during the start-up of the system.
In the worst case scenario, the da Vinci surgical system will encounter a non-recoverable fault, preventing use of the system. The error typically presents itself during start-up, so will not likely occur during a procedure (unless a mid-procedure power restart is required). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users that a representative will be replacing the affected compact flash cards with unaffected products. This may require users to re-enter their user preferences. This action has been closed-out on 27/01/2017. |
| Contact Information |
07 3623 1400 - Device Technologies |