FDA Device recall Z-0210-2018
SMARTABLATE RF System Generator
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of SMARTABLATE RF System Generator by Biosense Webster, citing generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0210-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-14 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biosense Webster |
| Distribution | CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI |
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.
Identifiers
| code_info | Product Codes M490006, M490007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2018%22
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