Z-0210-2018 Class II Terminated
FDA device recall Z-0210-2018 was initiated by Biosense Webster, Inc. on June 14, 2017 and is designated Class II. Reason for recall: Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. The recall status is terminated (terminated January 11, 2021). Affected quantity: 185 units total.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- June 14, 2017
- Termination Date
- January 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 185 units total
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.
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.
Code Information
Product Codes M490006, M490007