| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01543-1 |
| Product Name/Description |
da Vinci Xi Surgical System P6b Software
ARTG: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies has learned from the manufacturer, Intuitive Surgical, that the updated da Vinci Xi Surgical System User Manual and the updated da Vinci Xi Instrument and Accessory User Manual were not provided when the system upgrade was performed.
The user manuals will be forwarded to affected customers. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Device Technologies Australia will forward the updated manuals to affected customers.
Once the updated System User Manual and the updated Instruments & Accessories User Manual have been received, disregard the previous versions of the system User Manual and the Instruments & Accessories User Manual.
2. Ensure all relevant personnel at your facility are fully informed of this notice, including medical staff who perform da Vinci XiTM Surgery procedures.
3. Complete and return the supplied Reply Form to acknowledge receipt of this notice.
4. Retain a copy of this letter and the acknowledgement form within the updated System User Manual and the updated Instruments & Accessories User Manual of the da Vinci XiTM System.
This action has been closed out on 17/10/2018 |
| Contact Information |
07 3623 1400 - Device Technologies |