| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01658-1 |
| Product Name/Description |
Rosa One 3.1
(Surgical robot for spine and brain surgeries)
Item Number: ROSA00208
Serial Number: BS16001
ARTG Number: 278903 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Two software issues have been identified with the Rosa One 3.1.
1. Specific to Spinal Surgery application - A product complaint was received by the manufacturer that indicated a risk for robot collision. When driving the robot arm in a surgical procedure, the robot arm comes too close to the robot stand, which leads to the possiblity of colliding with the stand. This issue was further observed during multiple attempts to enable the function "clear the arm (cooperative mode)". The Rosanna Spine software (version 3.1.0.1225) was identified as non-conforming to the release design.
2. Specific to Brain Surgery application - Part of the Rosa One 3.1 Mario software (robot arm software) related to safety in the "cooperative mode" is currently deactivated. The risk of unwanted robot motion with an instrument into the anatomy is mitigated by this software measure.
To date, their have been no injuries reported due to these issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Software corrections for the Rosa One 3.1 will be performed on site. The Rosanna Spine software correction has occured. Until the Mario software for the brain application is modifed, usage of the device is to be limited to the spine application only. This action has been closed-out on 09/06/2017. |
| Contact Information |
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