Recall Z-0210-2018— Biosense Webster, Inc.
Class II · Terminated
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2017-06-14, terminated 2021-01-11. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-14
- Terminated
- 2021-01-11
- Firm location
- Irwindale, CA, United States
Product description
SMARTABLATE RF System Generator
Reason for recall
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.