Device product
SMARTABLATE RF System Generator
Z-0210-2018
Product summary
- Event
- Event 77575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 185 units total
- Official record key
device-enforcement:Z-0210-2018
Official wording
Reason: Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Code information: Product Codes M490006, M490007
Distribution pattern: Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.
Derived failure modes
-
Unknown
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.