Recall Z-0210-2018
Biosense Webster, Inc. · initiated June 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SMARTABLATE RF System Generator
Codes / lots: Product Codes M490006, M490007
Reason for recall
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
FDA-determined cause: Labeling design
Action taken
All new U.S. and OUS customers, who have purchased the SMARTABLATE" Generator system since the launch of the original field action in March 2015 to the time the IFU was updated in November 2015, will be notified. The previously distributed Field Safety Notification Letter for the SMARTABLATE" Generator (Part Numbers# M490006 and M490007) and customer Acknowledgement Form will be sent to these new customers. Instructions included review the Field Safety Notice carefully, provide the notice to appropriate personnel in facility, ensure the SMARTABLATE System Foot Pedal is not located within the Stereotaxis RMT Lab, complete and return the Acknowledgement Forms, and maintain awareness of the notice.
Details
- Recall number
- Z-0210-2018
- Initiated
- June 14, 2017
- Terminated
- January 11, 2021
- Product code
- LPB – Cardiac Ablation Percutaneous Catheter
- Quantity
- 185 units total
- Distribution
- 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.
- Recalling firm
- Biosense Webster, Inc., Irwindale, CA