FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: SMARTABLATE RF System Generator
- Recall number
- Z-0210-2018
- Recalling firm
- Biosense Webster, Inc.
- Product
- SMARTABLATE RF System Generator
- Status
- Terminated
- Initiated
- 2017-06-14
- Posted
- not on file
- Terminated
- 2021-01-11
- Reason
- Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
- Root cause
- Labeling design
- Action
- 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.
- 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.
- Lot, serial or model codes
- Product Codes M490006, M490007
- 510(k) numbers
- not on file
- PMA numbers
- ["P990071S017"]
- Product code
- LPB
- Firm FEI
- 3003113629
- Firm city
- Irwindale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28