Device product
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Z-0639-2018
Product summary
- Event
- Event 78944
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0639-2018
Official wording
Reason: Robot arm being sent to the wrong position
Code information: SP16008
Distribution pattern: Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Derived failure modes
-
Unknown
Robot arm being sent to the wrong position