Recall · FDA
Biosense Webster, Inc.
Biosense Webster, Inc. issued a Class II FDA recall (Z-0210-2018) initiated 2017-06-14: SMARTABLATE RF System Generator
| Company | Biosense Webster, Inc. |
|---|---|
| Recall number | Z-0210-2018 |
| Classification | Class II |
| Status | Terminated |
| Category | Devices |
| Initiated | 2017-06-14 |
| Product | SMARTABLATE RF System Generator |
| Reason | Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. |
FAQ
What did Biosense Webster, Inc. recall?
SMARTABLATE RF System Generator
Why was Biosense Webster, Inc.'s product recalled?
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.