Device product
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Z-0160-2018
Product summary
- Event
- Event 77626
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31 units
- Official record key
device-enforcement:Z-0160-2018
Official wording
Reason: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Code information: Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
Distribution pattern: US distribution in AR, GA, OH, MI, and TX.
Derived failure modes
-
Unknown
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).