Device product
ROSA Surgical Device 2.5.8
Z-0115-2018
Product summary
- Event
- Event 77743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 units
- Official record key
device-enforcement:Z-0115-2018
Official wording
Reason: Potential for software to change the final tool orientation for the command position without command.
Code information: Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062
Distribution pattern: AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
Derived failure modes
-
Unknown
Potential for software to change the final tool orientation for the command position without command.